Breast CancerCINDERELLANCT05196269
Comparing Decision on Aesthetics After Breast Cancer Locoregional Treatment.
A study testing Artificial Intelligence and Digital Health Arm in people with Breast Cancer, run by Fundacao Champalimaud at 6 sites in 5 countries.
Trial summary
Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Artificial Intelligence and Digital Health Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 8 Aug 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old
- Written informed consent
- Primary breast cancer in situ or invasive without evidence of systemic disease - non Stage IV or locally advanced non-operable breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Uni or Bilateral surgery even if prophylactic in one side
- Capacity to use a web-based app autonomously or with home-based support
Who cannot join
- Mastectomy without reconstruction
- Pregnancy or lactation
- Previous radiation to breast/chest (e.g., lymphoma)
- Previous ipsilateral breast surgery due to malignant disease.
- Other neoplasm in the last 5 years (excluding basal cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix)
- Severe skin disease that will contra-indicate the use of radiotherapy
- Prophylactic surgery
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Poland2 sites
Copernicus Mamma Centrum, Wojewodzkie Centrum Onkologii, Copernicus Podmiot Leczniczy
Gdansk, Pomeranian, 80-210
Gdański Uniwersytet Medyczny
Gdansk, Pomeranian, 80-210
Portugal1 site
Champalimaud Research and Clinical Centre, Champalimaud Foundation
Lisbon, Lisbon District, 1400-038
About this study
Official title: Comparing Decision on Match of Expectations and Aesthetics Using a Conventional Versus a Cloud-based Healthcare Platform Approach in Breast Cancer Patients Proposed for Locoregional Treatment: A Prospective Randomized Trial
Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, the aesthetic outcome could be completely different for patients undergoing the same surgery based on individual patient factors (e.g., age, body habitus). In the CINDERELLA trial, the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for the classification of aesthetic outcomes and matching data and photographs) integrated into CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial, the investigators plan to compare whether the application helped fulfil the expectations and lead to a better quality of life compared with the classical approach. In the classical approach (control arm), doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about the surgery and possible outcomes. In most centres, no photographic evaluation is done, and expectations are not measured. The CINDERELLA trial will help overcome miscommunication and potential boundaries in the patient's or physician's understanding of the potential outcomes of locoregional breast cancer treatment.
Read the detailed description
The CINDERELLA clinical trial will be an open, prospective randomized trial that Champalimaud Foundation will coordinate. Five clinical centres agreed to participate in the trial. The trial will be designed and reported according to the latest SPIRIT-AI and CONSORT-AI guidelines.
The randomization will be made by adopting a dynamical approach following the Minimization Method. Assignment of the recruited patients to the study arms will take into account the stratification of the participants (younger and older than 50 / breast-conserving or mastectomy / mastectomy with or without radiotherapy), aiming to reduce bias and confounding by assuring the balance of the group.
After being proposed to the trial and checked for all the eligibility criteria, patients will be given the complete patient information before signing the informed consent.
For the five centres, a minimum of 515 patients should be enrolled in each arm of the study. After randomization, the patient will either follow:
- - The intervention arm with the CINDERELLA APProach with the introduction and access to CANKADO with the BreLO AI system. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard patient-reported outcomes measures (PROMs) (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. After the photographic capture, the BreLO-AI will match the patient biometrics and images with the more identical case existing in the BreLO repository and already classified by the BCCT.core into excellent, good, fair and poor. The new patient can then visualize the results. In case of doubts, queries will be answered through the app or, if needed, by phone call or booking another appointment. Questionnaires and Photographs will be repeated after wound healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).
- - The control arm with the Conventional approach with a theoretical explanation by the doctor/nurse of the proposed locoregional treatment and possible outcomes. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard PROMs (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. In case of doubts, the patient will book another appointment with the doctor/nurse, as usually done in routine practice. Questionnaires and Photographs will be repeated after healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).
Digital Photography (same protocol for all participating centres) - a similar protocol for image capture will exist for all centres. The standalone photography with an automatic robot will be progressively implemented (www.photorobot.com).
DATA COLLECTION
PATIENT-RELATED FACTORS
- Date of birth, Weight / Height / BMI, Thoracic perimeter, Bra size and cup
- Education degree, Profession, Hobbies
- Marital status, Pregnancies and offspring
- Breast-feeding, Menopausal status
- Smoking
- Connective tissue diseases
- Confirmed Pathogenic Germline Variant
TUMOUR-RELATED FACTORS
- Unilateral (unifocal, multifocal, multicentric) Bilateral
- Histological type according to World Health Organization (WHO) classification (e.g., invasive ductal carcinoma, lobular carcinoma) (size in mm) staging ER, PR, Her2, Ki67, cTNM - pTNM / ypTNM
TREATMENT-RELATED FACTORS
*Type of Surgery/ Type of Reconstruction: (data collection regarding surgery should also include acellular dermal matrice (ADM) if used - type and placement) TYPE OF SURGERY: C1 - Conservative surgery - unilateral or bilateral, C2 - Conservative surgery with bilateral reduction (uni or bilateral), C3 - Conservative surgery with LD or LICAP/TDAP, C4 - Conservative surgery with bilateral breast augmentation, M1 - Mastectomy with unilateral reconstruction with implant, M2 - Mastectomy with unilateral reconstruction with autologous flap, M3 - Mastectomy with bilateral reconstruction with implants, M4 - Mastectomy with bilateral reconstruction with autologous flaps, M5 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with implant (augmentation), M6 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with reduction, M7 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with reduction, M8 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with implant (augmentation).
STATISTICAL ANALYSIS
An extensive descriptive analysis will be performed to characterize the groups in detail and the outcomes of the study at baseline as well as in the following points of data collection. Concerning the primary objectives, models of the class of generalized linear mixed models (in particular, multinomial regression models for ordinal data) will be estimated to evaluate the effect of the training and the women's characteristics on their evaluation of the aesthetic results of the surgery at each time and along time through longitudinal analysis. The Wilcoxon signed rank test for pairs will also be used to evaluate the effect of training on the level of agreement of the expectations and the final result. Weighted Cohen's k will be calculated for both groups (train and control) and compared using a statistical test and/or bootstrap techniques to assess the improvement in the ability to classify the aesthetic result of their surgery provided by training. A measure of similarity between self-evaluation and the BCCT.core will be computed for each participant, and a beta regression model will be estimated to assess the effect of training, controlling variables that can play as confounders, such as women's and disease characteristics at each time point and in a longitudinal perspective. Concerning the secondary objectives, the patient-reported outcome measures administered will be scored according to the official guidelines provided by the developers of the instruments. Besides the descriptive statistics, the outcomes will be compared between groups using adequate statistical tests. Again, models of the class of the general linear mixed models will be used.
- Conditions
- Breast Cancer
- Being tested
- Artificial Intelligence and Digital Health Arm
- Keywords
- Breast cancer, Surgery, Radiation, Artificial Intelligence, Outcomes, Aesthetics, Expectations, Satisfaction, Quality of life, Digital Platform
- Medical subject headings
- Breast Neoplasms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence and Digital Health ArmDevice
Also called Artificial Intelligence and cloud-based digital health platform
A previous large database repository of images having thousands of pre and postoperative photographs of breast cancer patients proposed for locoregional treatment with clinical and biometric data will be matched using artificial intelligence within the CANKADO platform. Patients proposed for breast cancer locoregional treatment will have access to the software installed, and they will have access to all the information about the type of treatment they will receive. All the questions and questionnaires will be filled out online, and they can visualise the expected outcome from excellent to poor.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence and Digital Health Arm | Experimental | Using an Artificial Intelligence approach integrated in a cloud-based healthcare platform CANKADO to give the patient complete information about the proposed type of locoregional treatment and access to photographs and data of patients with similar characteristics previously treated with the same technique. All interaction will be through the CANKADO Platform. Receives: Device: Artificial Intelligence and Digital Health Arm |
| Control Comparator | Other | The standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results. Receives: Device: Artificial Intelligence and Digital Health Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between patients expectations before and after treatment in both the intervention and the control arm
Agreement between patient's expectations about the aesthetic outcome measured before and after treatment, evaluated at 12 months after treatment (Cohen's Kappa and weighted Kappa Statistics) both the intervention and the control arm.
Measured: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Agreement about the aesthetic outcome between the objective evaluation and self- evaluation measured after treatment in both the intervention and the control arm
Agreement about the aesthetic outcome between the AI evaluation tool (BCT.core software) and self- evaluation after treatment (Cohen's Kappa and weighted Kappa Statistics) in both the intervention and the control arm.
Measured: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Secondary outcomes (3)
Patient's body image satisfaction after surgery measured through the BREAST-Q - International Consortium for Health Outcomes Measurement (ICHOM) questionnaire
Body image perception and satisfaction using the BREAST-Q ICHOM questionnaire. The scale scores from 0 lowest to 100 highest (body image satisfaction) in both the intervention and the control arm.
Measured: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Resource consumption a) time spent in hospital b) number of appointments c) duration until treatment d) out of pocket expenditure, additional care sought by patients
Resource consumption (cost per patient evaluated by the amount of appointments between the surgical proposal by the surgeon and the end of the trial) in both the intervention and control arm.
Measured: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done
Patient's general health-related quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire
How results impact in patients general quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire. The scale scores from 0 lowest to 100 highest. A high scale score represents a high/healthy level of functioning.
Measured: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start8 Aug 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open trial with parallel groups
- Masking
- None (open label)
- Enrolment
- 1,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal), Cankado GmbH, FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal), Bocconi University
- Responsible party
- Principal investigator, Maria-Joao Cardoso, Fundacao Champalimaud
- Investigators
- Maria-Joao Cardoso, MD, PhD, Principal investigator, Champalimaud Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196269
- Sponsor's protocol ID
- CINDERELLA
- Acronym
- CINDERELLA
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pilleron S, Soto-Perez-de-Celis E, Vignat J, Ferlay J, Soerjomataram I, Bray F, Sarfati D. Estimated global cancer incidence in the oldest adults in 2018 and projections to 2050. Int J Cancer. 2021 Feb 1;148(3):601-608. doi: 10.1002/ijc.33232. Epub 2020 Aug 17.
PubMed 32706917Kim MK, Kim T, Moon HG, Jin US, Kim K, Kim J, Lee JW, Kim J, Lee E, Yoo TK, Noh DY, Minn KW, Han W. Effect of cosmetic outcome on quality of life after breast cancer surgery. Eur J Surg Oncol. 2015 Mar;41(3):426-32. doi: 10.1016/j.ejso.2014.12.002. Epub 2014 Dec 19.
PubMed 25578249Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
PubMed 12393819Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.
PubMed 32162181Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.
PubMed 110740Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246Ong WL, Schouwenburg MG, van Bommel ACM, Stowell C, Allison KH, Benn KE, Browne JP, Cooter RD, Delaney GP, Duhoux FP, Ganz PA, Hancock P, Jagsi R, Knaul FM, Knip AM, Koppert LB, Kuerer HM, McLaughin S, Mureau MAM, Partridge AH, Reid DP, Sheeran L, Smith TJ, Stoutjesdijk MJ, Vrancken Peeters MJTFD, Wengstrom Y, Yip CH, Saunders C. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017 May 1;3(5):677-685. doi: 10.1001/jamaoncol.2016.4851.
PubMed 28033439Ciani O, Federici CB. Value Lies in the Eye of the Patients: The Why, What, and How of Patient-reported Outcomes Measures. Clin Ther. 2020 Jan;42(1):25-33. doi: 10.1016/j.clinthera.2019.11.016. Epub 2020 Jan 10.
PubMed 31932079Fitzal F, Krois W, Trischler H, Wutzel L, Riedl O, Kuhbelbock U, Wintersteiner B, Cardoso MJ, Dubsky P, Gnant M, Jakesz R, Wild T. The use of a breast symmetry index for objective evaluation of breast cosmesis. Breast. 2007 Aug;16(4):429-35. doi: 10.1016/j.breast.2007.01.013. Epub 2007 Mar 26.
PubMed 17382546Cardoso MJ, Cardoso J, Amaral N, Azevedo I, Barreau L, Bernardo M, Christie D, Costa S, Fitzal F, Fougo JL, Johansen J, Macmillan D, Mano MP, Regolo L, Rosa J, Teixeira L, Vrieling C. Turning subjective into objective: the BCCT.core software for evaluation of cosmetic results in breast cancer conservative treatment. Breast. 2007 Oct;16(5):456-61. doi: 10.1016/j.breast.2007.05.002. Epub 2007 Jul 2.
PubMed 17606373Cardoso JS, Cardoso MJ. Towards an intelligent medical system for the aesthetic evaluation of breast cancer conservative treatment. Artif Intell Med. 2007 Jun;40(2):115-26. doi: 10.1016/j.artmed.2007.02.007. Epub 2007 Apr 8.
PubMed 17420117Heil J, Dahlkamp J, Golatta M, Rom J, Domschke C, Rauch G, Cardoso MJ, Sohn C. Aesthetics in breast conserving therapy: do objectively measured results match patients' evaluations? Ann Surg Oncol. 2011 Jan;18(1):134-8. doi: 10.1245/s10434-010-1252-4. Epub 2010 Aug 10.
PubMed 20697820Cardoso MJ, Cardoso JS, Oliveira HP, Gouveia P. The breast cancer conservative treatment. Cosmetic results - BCCT.core - Software for objective assessment of esthetic outcome in breast cancer conservative treatment: A narrative review. Comput Methods Programs Biomed. 2016 Apr;126:154-9. doi: 10.1016/j.cmpb.2015.11.010. Epub 2015 Dec 9.
PubMed 26707372Cardoso JS, Silva W, Cardoso MJ. Evolution, current challenges, and future possibilities in the objective assessment of aesthetic outcome of breast cancer locoregional treatment. Breast. 2020 Feb;49:123-130. doi: 10.1016/j.breast.2019.11.006. Epub 2019 Nov 21.
PubMed 31790958
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Decision on Match of Expectations and Aesthetics Using a Conventional Versus a Cloud-based Healthcare Platform Approach in Breast Cancer Patients Proposed for Locoregional Treatment: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05196269
- Acronym / sponsor ID
- CINDERELLA / CINDERELLA
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Surgery, Radiation, Artificial Intelligence, Outcomes, Aesthetics, Expectations, Satisfaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Collaborators
- European Commission, INESC TEC - Institute for Systems and Computer Engineering, Technology and Science (Porto, Portugal), Cankado GmbH, FCiências.ID - Associação para a Investigação e Desenvolvimento de Ciências (Lisbon, Portugal), Bocconi University
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most commonly diagnosed cancer, with an estimated 2.3 million new cases per year globally. Approximately 90% of these patients will undergo breast surgery with/without radiation (locoregional treatment). Different surgical techniques can be offered to the patient, each leading to completely different aesthetic outcomes. Moreover, the aesthetic outcome could be completely different for patients undergoing the same surgery based on individual patient factors (e.g., age, body habitus). In the CINDERELLA trial, the investigators will be using the (Breast Locoregional (BreLO) AI system (an artificial intelligence-based tool for the classification of aesthetic outcomes and matching data and photographs) integrated into CANKADO (a cloud-based healthcare platform) to create an easy-to-use application that can be used on any electronic device, to simulate visually to the patient the aesthetic outcome of a certain surgery or radiation treatment. In the CINDERELLA trial, the investigators plan to compare whether the application helped fulfil the expectations and lead to a better quality of life compared with the classical approach. In the classical approach (control arm), doctors usually propose a locoregional treatment and explain theoretically how the result will be. Nurses help by explaining further details about the surgery and possible outcomes. In most centres, no photographic evaluation is done, and expectations are not measured. The CINDERELLA trial will help overcome miscommunication and potential boundaries in the patient's or physician's understanding of the potential outcomes of locoregional breast cancer treatment.
Detailed description
The CINDERELLA clinical trial will be an open, prospective randomized trial that Champalimaud Foundation will coordinate. Five clinical centres agreed to participate in the trial. The trial will be designed and reported according to the latest SPIRIT-AI and CONSORT-AI guidelines.
The randomization will be made by adopting a dynamical approach following the Minimization Method. Assignment of the recruited patients to the study arms will take into account the stratification of the participants (younger and older than 50 / breast-conserving or mastectomy / mastectomy with or without radiotherapy), aiming to reduce bias and confounding by assuring the balance of the group.
After being proposed to the trial and checked for all the eligibility criteria, patients will be given the complete patient information before signing the informed consent.
For the five centres, a minimum of 515 patients should be enrolled in each arm of the study. After randomization, the patient will either follow:
- - The intervention arm with the CINDERELLA APProach with the introduction and access to CANKADO with the BreLO AI system. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard patient-reported outcomes measures (PROMs) (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. After the photographic capture, the BreLO-AI will match the patient biometrics and images with the more identical case existing in the BreLO repository and already classified by the BCCT.core into excellent, good, fair and poor. The new patient can then visualize the results. In case of doubts, queries will be answered through the app or, if needed, by phone call or booking another appointment. Questionnaires and Photographs will be repeated after wound healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).
- - The control arm with the Conventional approach with a theoretical explanation by the doctor/nurse of the proposed locoregional treatment and possible outcomes. The Expectations Questionnaire, Healthcare Professionals Multidimensional Evaluation Questionnaire and standard PROMs (EQ-5D-5L and BREAST Q ICHOM) will be filed electronically. Standard photographic capture will be taken at this point. In case of doubts, the patient will book another appointment with the doctor/nurse, as usually done in routine practice. Questionnaires and Photographs will be repeated after healing is complete, six months and one year after the end of treatment (surgery or radiotherapy if radiotherapy was done).
Digital Photography (same protocol for all participating centres) - a similar protocol for image capture will exist for all centres. The standalone photography with an automatic robot will be progressively implemented (www.photorobot.com).
DATA COLLECTION
PATIENT-RELATED FACTORS
- Date of birth, Weight / Height / BMI, Thoracic perimeter, Bra size and cup
- Education degree, Profession, Hobbies
- Marital status, Pregnancies and offspring
- Breast-feeding, Menopausal status
- Smoking
- Connective tissue diseases
- Confirmed Pathogenic Germline Variant
TUMOUR-RELATED FACTORS
- Unilateral (unifocal, multifocal, multicentric) Bilateral
- Histological type according to World Health Organization (WHO) classification (e.g., invasive ductal carcinoma, lobular carcinoma) (size in mm) staging ER, PR, Her2, Ki67, cTNM - pTNM / ypTNM
TREATMENT-RELATED FACTORS
*Type of Surgery/ Type of Reconstruction: (data collection regarding surgery should also include acellular dermal matrice (ADM) if used - type and placement) TYPE OF SURGERY: C1 - Conservative surgery - unilateral or bilateral, C2 - Conservative surgery with bilateral reduction (uni or bilateral), C3 - Conservative surgery with LD or LICAP/TDAP, C4 - Conservative surgery with bilateral breast augmentation, M1 - Mastectomy with unilateral reconstruction with implant, M2 - Mastectomy with unilateral reconstruction with autologous flap, M3 - Mastectomy with bilateral reconstruction with implants, M4 - Mastectomy with bilateral reconstruction with autologous flaps, M5 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with implant (augmentation), M6 - Mastectomy with unilateral reconstruction with implant and contralateral symmetrisation with reduction, M7 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with reduction, M8 - Mastectomy with unilateral reconstruction with autologous flap and contralateral symmetrisation with implant (augmentation).
STATISTICAL ANALYSIS
An extensive descriptive analysis will be performed to characterize the groups in detail and the outcomes of the study at baseline as well as in the following points of data collection. Concerning the primary objectives, models of the class of generalized linear mixed models (in particular, multinomial regression models for ordinal data) will be estimated to evaluate the effect of the training and the women's characteristics on their evaluation of the aesthetic results of the surgery at each time and along time through longitudinal analysis. The Wilcoxon signed rank test for pairs will also be used to evaluate the effect of training on the level of agreement of the expectations and the final result. Weighted Cohen's k will be calculated for both groups (train and control) and compared using a statistical test and/or bootstrap techniques to assess the improvement in the ability to classify the aesthetic result of their surgery provided by training. A measure of similarity between self-evaluation and the BCCT.core will be computed for each participant, and a beta regression model will be estimated to assess the effect of training, controlling variables that can play as confounders, such as women's and disease characteristics at each time point and in a longitudinal perspective. Concerning the secondary objectives, the patient-reported outcome measures administered will be scored according to the official guidelines provided by the developers of the instruments. Besides the descriptive statistics, the outcomes will be compared between groups using adequate statistical tests. Again, models of the class of the general linear mixed models will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized open trial with parallel groups
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence and Digital Health Arm | Experimental | Device: Artificial Intelligence and Digital Health ArmUsing an Artificial Intelligence approach integrated in a cloud-based healthcare platform CANKADO to give the patient complete information about the proposed type of locoregional treatment and access to photographs and data of patients with similar characteristics previously treated with the same technique. All interaction will be through the CANKADO Platform. |
| Control Comparator | Other | Device: Artificial Intelligence and Digital Health ArmThe standard approach of proposing patients for locoregional treatment with or without printed or digital materials and hypothetic visualization of results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- More than 18 years old
- Written informed consent
- Primary breast cancer in situ or invasive without evidence of systemic disease - non Stage IV or locally advanced non-operable breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Uni or Bilateral surgery even if prophylactic in one side
Key exclusion criteria (7 listed)
- Mastectomy without reconstruction
- Pregnancy or lactation
- Previous radiation to breast/chest (e.g., lymphoma)
- Previous ipsilateral breast surgery due to malignant disease.
- Other neoplasm in the last 5 years (excluding basal cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence and Digital Health ArmAlso: Artificial Intelligence and cloud-based digital health platformA previous large database repository of images having thousands of pre and postoperative photographs of breast cancer patients proposed for locoregional treatment with clinical and biometric data will be matched using artificial intelligence within the CANKADO platform. Patients proposed for breast cancer locoregional treatment will have access to the software installed, and they will have access to all the information about the type of treatment they will receive. All the questions and questionnaires will be filled out online, and they can visualise the expected outcome from excellent to poor. | Device | Artificial Intelligence and Digital Health Arm, Control Comparator |
Primary outcome
Agreement between patients expectations before and after treatment in both the intervention and the control arm
Time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Agreement between patient's expectations about the aesthetic outcome measured before and after treatment, evaluated at 12 months after treatment (Cohen's Kappa and weighted Kappa Statistics) both the intervention and the control arm.
Agreement about the aesthetic outcome between the objective evaluation and self- evaluation measured after treatment in both the intervention and the control arm
Time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Agreement about the aesthetic outcome between the AI evaluation tool (BCT.core software) and self- evaluation after treatment (Cohen's Kappa and weighted Kappa Statistics) in both the intervention and the control arm.
3 secondary outcomes
Patient's body image satisfaction after surgery measured through the BREAST-Q - International Consortium for Health Outcomes Measurement (ICHOM) questionnaire
Time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Resource consumption a) time spent in hospital b) number of appointments c) duration until treatment d) out of pocket expenditure, additional care sought by patients
Time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done
Patient's general health-related quality of life evaluated in both the intervention and control arm with the EQ-5D-5L questionnaire
Time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 32706917Pilleron S, Soto-Perez-de-Celis E, Vignat J, Ferlay J, Soerjomataram I, Bray F, Sarfati D. Estimated global cancer incidence in the oldest adults in 2018 and projections to 2050. Int J Cancer. 2021 Feb 1;148(3):601-608. doi: 10.1002/ijc.33232. Epub 2020 Aug 17.
- Background: PubMed 25578249Kim MK, Kim T, Moon HG, Jin US, Kim K, Kim J, Lee JW, Kim J, Lee E, Yoo TK, Noh DY, Minn KW, Han W. Effect of cosmetic outcome on quality of life after breast cancer surgery. Eur J Surg Oncol. 2015 Mar;41(3):426-32. doi: 10.1016/j.ejso.2014.12.002. Epub 2014 Dec 19.
- Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
- Background: PubMed 12393819Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.
- Background: PubMed 32162181Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.
- Background: PubMed 110740Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.
- Background: PubMed 19644246Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
- Background: PubMed 28033439Ong WL, Schouwenburg MG, van Bommel ACM, Stowell C, Allison KH, Benn KE, Browne JP, Cooter RD, Delaney GP, Duhoux FP, Ganz PA, Hancock P, Jagsi R, Knaul FM, Knip AM, Koppert LB, Kuerer HM, McLaughin S, Mureau MAM, Partridge AH, Reid DP, Sheeran L, Smith TJ, Stoutjesdijk MJ, Vrancken Peeters MJTFD, Wengstrom Y, Yip CH, Saunders C. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017 May 1;3(5):677-685. doi: 10.1001/jamaoncol.2016.4851.
- Background: PubMed 31932079Ciani O, Federici CB. Value Lies in the Eye of the Patients: The Why, What, and How of Patient-reported Outcomes Measures. Clin Ther. 2020 Jan;42(1):25-33. doi: 10.1016/j.clinthera.2019.11.016. Epub 2020 Jan 10.
- Background: PubMed 17382546Fitzal F, Krois W, Trischler H, Wutzel L, Riedl O, Kuhbelbock U, Wintersteiner B, Cardoso MJ, Dubsky P, Gnant M, Jakesz R, Wild T. The use of a breast symmetry index for objective evaluation of breast cosmesis. Breast. 2007 Aug;16(4):429-35. doi: 10.1016/j.breast.2007.01.013. Epub 2007 Mar 26.
- Background: PubMed 17606373Cardoso MJ, Cardoso J, Amaral N, Azevedo I, Barreau L, Bernardo M, Christie D, Costa S, Fitzal F, Fougo JL, Johansen J, Macmillan D, Mano MP, Regolo L, Rosa J, Teixeira L, Vrieling C. Turning subjective into objective: the BCCT.core software for evaluation of cosmetic results in breast cancer conservative treatment. Breast. 2007 Oct;16(5):456-61. doi: 10.1016/j.breast.2007.05.002. Epub 2007 Jul 2.
- Background: PubMed 17420117Cardoso JS, Cardoso MJ. Towards an intelligent medical system for the aesthetic evaluation of breast cancer conservative treatment. Artif Intell Med. 2007 Jun;40(2):115-26. doi: 10.1016/j.artmed.2007.02.007. Epub 2007 Apr 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria-Joao Cardoso, MD, PhD principal investigator
Champalimaud Foundation
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence and Digital Health Arm in people with Breast Cancer, run by Fundacao Champalimaud at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Germany, Israel, Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between patients expectations before and after treatment in both the intervention and the control arm (time frame: 12 months after locoregional treatment (surgery or radiotherapy in case adjuvant radiotherapy is done)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196269, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.