Atypical Ductal HyperplasiaNCT05932758
Excisional Vacuum-Assisted Breast Biopsy
A study testing Vacuum-assisted excisional biopsy and Not excisional biopsy in people with Atypical Ductal Hyperplasia and Ductal Carcinoma in Situ, run by European Institute of Oncology at 1 site in Italy.
Trial summary
The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Atypical Ductal Hyperplasia, Ductal Carcinoma in Situ
- What is being tested?
- Vacuum-assisted excisional biopsy and Not excisional biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspicious breast lesions (BIRADS >3)
- Patients with a lesion <= of 15mm.
- Capable and willing to comply the specific informed consent form
- Patients with ADH biopsy results or low intermediate-grade DCIS
- Patients who will undergo surgery
Who cannot join
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Trial locations and contacts
1 site in 1 country.
Claudia Sangalli, MSc contact
Italy1 site, 1 recruiting
- Recruiting
Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Milan, 20141
Luca Nicosia, MD
About this study
Official title: Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast
The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).
Read the detailed description
Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.
Patients with suspicious breast lesions (BIRADS>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.
The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.
- Being tested
- Vacuum-assisted excisional biopsy, Not excisional biopsy
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum-assisted excisional biopsyProcedure or surgery
at least 4g of tissue sampled (excisional biopsy)
Not excisional biopsyProcedure or surgery
biopsy with less than 4 g of tissue sampled
| Study group | Role | What they receive |
|---|---|---|
| no excisional biopsy | Other | Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled) Receives: Procedure: Not excisional biopsy |
| excisional biosy | Experimental | Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled) Receives: Procedure: Vacuum-assisted excisional biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete removal of lesion
Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start17 Jan 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atypical Ductal HyperplasiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Responsible party
- Sponsor
- Investigators
- Luca Nicosia, MD, Principal investigator, European Institute of Oncology IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932758
- Sponsor's protocol ID
- IEO 1856
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nicosia L, Mariano L, Latronico A, Bozzini AC, Bellerba F, Gaeta A, Pesapane F, Mazzarol G, Fusco N, Corso G, Sangalli C, Gialain C, Lazzeroni M, Raimondi S, Cassano E. Exploring non-surgical alternatives for low to intermediate-grade in situ ductal carcinoma of the breast using vacuum-assisted excision: the VACIS protocol. Front Med (Lausanne). 2024 Sep 24;11:1467738. doi: 10.3389/fmed.2024.1467738. eCollection 2024.
PubMed 39380737
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast
- ClinicalTrials.gov ID
- NCT05932758
- Acronym / sponsor ID
- IEO 1856
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 6 Jul 2023 (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.
The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).
Detailed description
Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.
Patients with suspicious breast lesions (BIRADS>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.
The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no excisional biopsy | Other | Procedure: Not excisional biopsyPatients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled) |
| excisional biosy | Experimental | Procedure: Vacuum-assisted excisional biopsyPatients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with suspicious breast lesions (BIRADS >3)
- Patients with a lesion <= of 15mm.
- Capable and willing to comply the specific informed consent form
- Patients with ADH biopsy results or low intermediate-grade DCIS
- Patients who will undergo surgery
Key exclusion criteria (1 listed)
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
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 |
|---|---|---|
| Vacuum-assisted excisional biopsyat least 4g of tissue sampled (excisional biopsy) | Procedure or surgery | excisional biosy |
| Not excisional biopsybiopsy with less than 4 g of tissue sampled | Procedure or surgery | no excisional biopsy |
Primary outcome
Percentage of patients with complete removal of lesion
Time frame: 6 months
Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 39380737Nicosia L, Mariano L, Latronico A, Bozzini AC, Bellerba F, Gaeta A, Pesapane F, Mazzarol G, Fusco N, Corso G, Sangalli C, Gialain C, Lazzeroni M, Raimondi S, Cassano E. Exploring non-surgical alternatives for low to intermediate-grade in situ ductal carcinoma of the breast using vacuum-assisted excision: the VACIS protocol. Front Med (Lausanne). 2024 Sep 24;11:1467738. doi: 10.3389/fmed.2024.1467738. eCollection 2024.
Related trials for Atypical Ductal Hyperplasia
Active, not recruitingPhase 3
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
Breast Atypical Ductal Hyperplasia, Breast Ductal Carcinoma In Situ
RecruitingPhase 2
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
Breast Atypical Hyperplasia, Breast Carcinoma
RecruitingPhase 2
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
Breast Atypical Ductal Hyperplasia, Breast Atypical Lobular Hyperplasia
RecruitingPhase 2
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer
Breast Atypical Hyperplasia, Breast Carcinoma
RecruitingObservational study
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
Breast Atypical Ductal Hyperplasia, Breast Atypical Lobular Hyperplasia
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.
Claudia Sangalli, MSc contact
Luca Nicosia, MD principal investigator
European Institute of Oncology IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum-assisted excisional biopsy and Not excisional biopsy in people with Atypical Ductal Hyperplasia and Ductal Carcinoma in Situ, run by European Institute of Oncology at 1 site in Italy.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Nicosia, MD (+390294372449, luca.nicosia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete removal of lesion (time frame: 6 months). 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 NCT05932758, which also lists 1 linked publication.
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 21 Jul 2023.