Breast CancerNCT06425874
The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery
An observational study of Breast Cancer and Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Breast-conserving surgery is the standard treatment for young breast cancer patients, while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer, Surgery, Quality of Life
- What is being tested?
- Breast-conserving surgery, Mastectomy and Mastectomy with reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 1 Dec 2035
- Phase
- Observational
- 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 to 50 years
- Women only
- Adult
Study population: Young breast cancer women.
Who may be able to join
- Age between 18 and 50 years old.
- The surgery time and procedure have been confirmed, and the surgical informed consent and research informed consent forms have been signed.
- Informed consent obtained from patient.
- Unilateral Breast Cancer.
- Good health,the patient is able to tolerate general anesthesia and surgery, with an ECOG performance status of ≤2 points.
- No history of breast/axillary radiation therapy.
- Willing and capable of complying with the study protocol visits, treatment plans, and other research procedures.
Who cannot join
- Bilateral breast cancer.
- Inflammatory breast cancer.
- Stage IV breast cancer.
- Physical examination and imaging suggest tumor infiltration into the skin, pectoralis major muscle, and other adjacent tissues.
- Patients unable to tolerate surgery due to coagulation abnormalities.
- In patients without evidence of breast cancer in the contralateral breast, requesting contralateral prophylactic mastectomy.
Show all 9Show fewer
- In patients who have undergone surgical treatment for breast cancer (including mastectomy, breast-conserving surgery, and mastectomy with implant reconstruction), requesting secondary breast surgery.
- Patients with a history or current diagnosis of other malignancies, excluding thyroid cancer.
- The conditions considered unsuitable for inclusion by researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong
Kai Chen, MD
About this study
Official title: The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery: an Observational Cohort Study
Breast-conserving surgery is the standard treatment for young breast cancer patients, while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery. Several studies have compared the quality of life and patient satisfaction among individuals receiving different types of surgery (Breast-conserving surgery, mastectomy alone, or mastectomy with reconstruction). For example, Meghan R. demonstrated that patients undergoing Breast-conserving surgery experience a higher quality of life compared to those undergoing mastectomy with breast reconstruction, whereas J. Dauplat's study showed that patients who undergo mastectomy with breast reconstruction report a higher quality of life than those who undergo mastectomy alone.
However, the investigators hypothesize that the advantages of a specific type of surgery over another, such as Breast-conserving surgery versus breast reconstruction, may vary among patients with different socioeconomic factors. For instance, the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle.
Additionally, the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up. Furthermore, it is worth noting that most current studies have been conducted in Caucasian populations. In contrast to Caucasians, Asians typically have smaller breast volumes, potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes. Therefore, a study focusing on Asian young breast cancer populations is necessary.
Read the detailed description
This study is a prospective, observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms: Breast-conserving surgery, mastectomy alone, and mastectomy with breast reconstruction, based on their clinical decisions and preferences. Clinicopathological features (age,Tumor, Node, Metastasis stages, pathological features, etc.), socioeconomic determinants (education level, income, insurance status, marital status, occupational status, personality, etc.), treatment information (neoadjuvant chemotherapy or not, post-operative complications), and survival (local recurrence, metastasis) will be recorded.
All patients will be followed at 6 and 12 months for the first year after diagnosis, then yearly thereafter for an additional 9 years (for a total follow-up of at least 10 years following diagnosis). During the post-operative follow-up, quality of life, psychological well-being, decision regret, surgical information, treatment costs, and surveillance-follow-up will be recorded.
The primary endpoint of this study is the quality of life, assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary endpoints include decisional conflict scale, decision regret scales, and the Hospital Anxiety and Depression Scale (HADS).
The primary and secondary endpoints will be compared among the three arms, and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated. Additionally, the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants.
- Conditions
- Breast Cancer, Surgery, Quality of Life
- Being tested
- Breast-conserving surgery, Mastectomy, Mastectomy with reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-conserving surgeryProcedure or surgery
Breast-conserving surgery
MastectomyProcedure or surgery
Mastectomy without reconstruction
Mastectomy with reconstructionProcedure or surgery
Any type of reconstruction(include implant and autologous)
| Study group | Role | What they receive |
|---|---|---|
| Breast-conserving surgery | Not described Receives: Procedure: Breast-conserving surgery | |
| Mastectomy | Not described Receives: Procedure: Mastectomy | |
| Mastectomy with reconstruction | Not described Receives: Procedure: Mastectomy with reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0
Utilizing the BREAST-Q questionnaire, this measure assesses women's self-reported satisfaction with their breasts and associated quality of life, encompassing psychosocial, sexual, and physical well-being. Scores range from 0 (worst) to 100 (best), with higher scores indicating a more favorable outcome.Assessment is conducted preoperatively and 10 years postoperatively.
Measured: Pre-operation and 10 years
Participant's health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), this self-administered questionnaire consists of 30 items designed to evaluate the health-related quality of life among cancer patients. For questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome.Assessment is conducted 10 years postoperatively.
Measured: 10 years
Secondary outcomes (3)
Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire
Administered pre-operation, this tool evaluates the patient's conflict regarding the decision for surgery. Each item is rated on a Likert Scale with five responses, ranging from 0 ("Not at All") to 4 ("Extremely"), resulting in a total score ranging from 0 (Less conflicted) to 100 (Highly conflicted).Assessment is conducted preoperatively.
Measured: Pre-Operative
Participant's decision regret assessed by Decision Regret Scale questionnaire
Conducted during follow-up sessions, this assessment captures the patient's sentiments and remorse regarding the treatment-related decision to undergo surgery. Five items specifically inquire about feelings of regret. Scores range from 0 to 100, with a higher score indicating a greater level of decision-related regret.Assessment is conducted 10 years postoperatively.
Measured: 10 years
Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire
Administered during follow-ups, this scale measures the patient's psychological change. The HADS comprises two 7-item subscales assessing depression and anxiety symptoms separately. Higher scores indicate greater levels of depression and/or anxiety.Assessment is conducted preoperatively and 10 years postoperatively.
Measured: Pre-operation and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start29 Feb 2024
- Primary completion1 Dec 2035 (estimated)
- Study completion1 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Kai, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425874
- Sponsor's protocol ID
- SYSKY-2024-147-01
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests.
Publications
Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. 2021 Oct 1;156(10):e213758. doi: 10.1001/jamasurg.2021.3758. Epub 2021 Oct 13.
PubMed 34468718Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
PubMed 35416926Diao K, Lei X, He W, Jagsi R, Giordano SH, Smith GL, Caudle A, Shen Y, Peterson SK, Smith BD. Patient-reported Quality of Life After Breast-conserving Surgery With Radiotherapy Versus Mastectomy and Reconstruction. Ann Surg. 2023 Nov 1;278(5):e1096-e1102. doi: 10.1097/SLA.0000000000005920. Epub 2023 May 26.
PubMed 37232937Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivors. JAMA Surg. 2020 Nov 1;155(11):1035-1042. doi: 10.1001/jamasurg.2020.3325.
PubMed 32936216Riba LA, Gruner RA, Alapati A, James TA. Association between socioeconomic factors and outcomes in breast cancer. Breast J. 2019 May;25(3):488-492. doi: 10.1111/tbj.13250. Epub 2019 Apr 15.
PubMed 30983100Flanagan MR, Zabor EC, Romanoff A, Fuzesi S, Stempel M, Mehrara BJ, Morrow M, Pusic AL, Gemignani ML. A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction. Ann Surg Oncol. 2019 Oct;26(10):3133-3140. doi: 10.1245/s10434-019-07548-9. Epub 2019 Jul 24.
PubMed 31342397Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12.
PubMed 28401542
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06425874
- Acronym / sponsor ID
- SYSKY-2024-147-01
- Conditions
- Breast Cancer, Surgery, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 1 Dec 2035 (estimated)
- Study completion
- 1 Dec 2035 (estimated)
- First posted
- 22 May 2024 (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-conserving surgery is the standard treatment for young breast cancer patients, while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery. Several studies have compared the quality of life and patient satisfaction among individuals receiving different types of surgery (Breast-conserving surgery, mastectomy alone, or mastectomy with reconstruction). For example, Meghan R. demonstrated that patients undergoing Breast-conserving surgery experience a higher quality of life compared to those undergoing mastectomy with breast reconstruction, whereas J. Dauplat's study showed that patients who undergo mastectomy with breast reconstruction report a higher quality of life than those who undergo mastectomy alone.
However, the investigators hypothesize that the advantages of a specific type of surgery over another, such as Breast-conserving surgery versus breast reconstruction, may vary among patients with different socioeconomic factors. For instance, the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle.
Additionally, the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up. Furthermore, it is worth noting that most current studies have been conducted in Caucasian populations. In contrast to Caucasians, Asians typically have smaller breast volumes, potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes. Therefore, a study focusing on Asian young breast cancer populations is necessary.
Detailed description
This study is a prospective, observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms: Breast-conserving surgery, mastectomy alone, and mastectomy with breast reconstruction, based on their clinical decisions and preferences. Clinicopathological features (age,Tumor, Node, Metastasis stages, pathological features, etc.), socioeconomic determinants (education level, income, insurance status, marital status, occupational status, personality, etc.), treatment information (neoadjuvant chemotherapy or not, post-operative complications), and survival (local recurrence, metastasis) will be recorded.
All patients will be followed at 6 and 12 months for the first year after diagnosis, then yearly thereafter for an additional 9 years (for a total follow-up of at least 10 years following diagnosis). During the post-operative follow-up, quality of life, psychological well-being, decision regret, surgical information, treatment costs, and surveillance-follow-up will be recorded.
The primary endpoint of this study is the quality of life, assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary endpoints include decisional conflict scale, decision regret scales, and the Hospital Anxiety and Depression Scale (HADS).
The primary and secondary endpoints will be compared among the three arms, and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated. Additionally, the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast-conserving surgery | – | Procedure: Breast-conserving surgery |
| Mastectomy | – | Procedure: Mastectomy |
| Mastectomy with reconstruction | – | Procedure: Mastectomy with reconstruction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Young breast cancer women.
Key inclusion criteria (7 listed)
- Age between 18 and 50 years old.
- The surgery time and procedure have been confirmed, and the surgical informed consent and research informed consent forms have been signed.
- Informed consent obtained from patient.
- Unilateral Breast Cancer.
- Good health,the patient is able to tolerate general anesthesia and surgery, with an ECOG performance status of ≤2 points.
Key exclusion criteria (9 listed)
- Bilateral breast cancer.
- Inflammatory breast cancer.
- Stage IV breast cancer.
- Physical examination and imaging suggest tumor infiltration into the skin, pectoralis major muscle, and other adjacent tissues.
- Patients unable to tolerate surgery due to coagulation abnormalities.
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 |
|---|---|---|
| Breast-conserving surgeryBreast-conserving surgery | Procedure or surgery | Breast-conserving surgery |
| MastectomyMastectomy without reconstruction | Procedure or surgery | Mastectomy |
| Mastectomy with reconstructionAny type of reconstruction(include implant and autologous) | Procedure or surgery | Mastectomy with reconstruction |
Primary outcome
Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0
Time frame: Pre-operation and 10 years
Utilizing the BREAST-Q questionnaire, this measure assesses women's self-reported satisfaction with their breasts and associated quality of life, encompassing psychosocial, sexual, and physical well-being. Scores range from 0 (worst) to 100 (best), with higher scores indicating a more favorable outcome.Assessment is conducted preoperatively and 10 years postoperatively.
Participant's health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 10 years
Assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), this self-administered questionnaire consists of 30 items designed to evaluate the health-related quality of life among cancer patients. For questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome.Assessment is conducted 10 years postoperatively.
3 secondary outcomes
Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire
Time frame: Pre-Operative
Participant's decision regret assessed by Decision Regret Scale questionnaire
Time frame: 10 years
Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire
Time frame: Pre-operation and 10 years
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 22 May 2024.
- Background: PubMed 34468718Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. 2021 Oct 1;156(10):e213758. doi: 10.1001/jamasurg.2021.3758. Epub 2021 Oct 13.
- Background: PubMed 35416926Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.
- Background: PubMed 37232937Diao K, Lei X, He W, Jagsi R, Giordano SH, Smith GL, Caudle A, Shen Y, Peterson SK, Smith BD. Patient-reported Quality of Life After Breast-conserving Surgery With Radiotherapy Versus Mastectomy and Reconstruction. Ann Surg. 2023 Nov 1;278(5):e1096-e1102. doi: 10.1097/SLA.0000000000005920. Epub 2023 May 26.
- Background: PubMed 32936216Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivors. JAMA Surg. 2020 Nov 1;155(11):1035-1042. doi: 10.1001/jamasurg.2020.3325.
- Background: PubMed 30983100Riba LA, Gruner RA, Alapati A, James TA. Association between socioeconomic factors and outcomes in breast cancer. Breast J. 2019 May;25(3):488-492. doi: 10.1111/tbj.13250. Epub 2019 Apr 15.
- Background: PubMed 31342397Flanagan MR, Zabor EC, Romanoff A, Fuzesi S, Stempel M, Mehrara BJ, Morrow M, Pusic AL, Gemignani ML. A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction. Ann Surg Oncol. 2019 Oct;26(10):3133-3140. doi: 10.1245/s10434-019-07548-9. Epub 2019 Jul 24.
- Background: PubMed 28401542Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12.
- Individual participant dataSharing planned: No. The study protocol and the raw and clean data for analysis will be shared among the participated researchers. Non-researchers could obtain relevant informations from the researchers upon reasonable requests.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Kai Chen, MD (15920164730 ext. 86, chenkai23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0 (time frame: Pre-operation and 10 years). 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 NCT06425874, which also lists 7 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 22 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.