Breast CancerNOMAT01NCT02523612
Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions
A study testing Biopsy and Blood sample in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biopsy and Blood sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2015to 25 Jun 2018
- 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
- Women who have had a recent diagnosis of atypical breast lesions (atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ) on a breast biopsy for microcalcifications on mammography Or for little suspect distortion in ultrasound or mammary MRI.
- Report of the anatomopathological examination of the biopsy allowing the diagnosis of an atypical lesion available
- Patient 18 years or more
- Informed consent signed.
- Patient affiliated to a system of social security or beneficiary of such plan
- General condition ECOG-OMS 0 or 1
Who cannot join
- Nodular lesion associated with ultrasound or mammography opacity
- Palpable nodule
- Presence of ductal carcinoma in situ or invasive carcinoma associated to biopsy
- Personal history of breast cancer or homo contralateral
- Previous history of breast irradiation or breast cancer or other area for malignancy (Hodgkin, etc ...)
- Women with a BRCA1 or BRCA2 mutation diagnosed or other genetic predisposition to breast cancer and highly penetrant autosomal dominant.
Show all 10Show fewer
- Pregnant or nursing women
- Women with a cons-indication or refusal of surgery
- Private Women of freedom under guardianship.
- Presence of aggressive lobular in situ carcinoma (pléioforme, Florida or necrosis)
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, 94805
About this study
Official title: Prospective National Multicentre Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks:
- The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer).
- These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation.
Read more
The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance.
This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.
- Conditions
- Breast Cancer
- Being tested
- Biopsy, Blood sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Blood sampleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with atypical lesions | Experimental | Not described Receives: Procedure: Biopsy; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive value of the NOMAT model
The primary endpoint is the negative predictive value (NPV) of Nomat model used to predict the absence of breast cancer associated with cases of atypical lesions in breast biopsy
Measured: Up to 3 months
Secondary outcomes (1)
Exploratory research for biomarkers using DNA Seq
The study will be Nomat parallel homogeneous database of prospective clinical and pathological data of patients operated for atypical breast lesions associated with tissue and blood samples (5 mL in EDTA tube).
This bank will exploratory research of new biomarkers and validation of new biomarkers that may emerge in the coming years.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start24 Jun 2015
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523612
- Sponsor's protocol ID
- 2015-A00045-44
- Other IDs
- 2015/2211
- Acronym
- NOMAT01
- Status last verified
- Jul 2018
- First submitted
- 6 Aug 2015
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Uzan C, Mazouni C, Rossoni C, De Korvin B, de Lara CT, Cohen M, Chabbert N, Zilberman S, Boussion V, Vincent Salomon A, Espie M, Coutant C, Marchal F, Salviat F, Boulanger L, Doutriaux-Dumoulin I, Jouve E, Mathelin C, de Saint Hilaire P, Mollard J, Balleyguier C, Joyon N, Triki ML, Delaloge S, Michiels S. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions. Ann Surg Oncol. 2021 Apr;28(4):2138-2145. doi: 10.1245/s10434-020-09107-z. Epub 2020 Sep 12.
PubMed 32920723
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective National Multicentre Study to Validate a Model of Surgical Deescalation in Atypicals Breast Lesions
- ClinicalTrials.gov ID
- NCT02523612
- Acronym / sponsor ID
- NOMAT01 / 2015-A00045-44
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 24 Jun 2015 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 14 Aug 2015 (estimated)
- 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.
Routine screening mammography has increased the non-palpable suspicious lesion detection rate, requiring histopathological evaluation. The discovery of atypical lesions on the breast biopsy is associated with two interrelated risks:
- The risk of underestimating the severity of the lesion biopsied currently leads systematically to achieve a surgical resection for these patients while a breast cancer (BC) will finally identified at surgery in 10 to 25% of cases. Thus, unnecessary surgeries will be performed in 75 to 90% of cases (no cancer).
- These breast lesions confer long-term increase in the subsequent risk of breast cancer (cumulative incidence of 15 to 25% at 25 years). Thus, women identified with atypical lesions are then followed using clinical and mammographic annual evaluation.
The goal would be to get a model to assess the risk and no longer operate those patients at high risk of BC. Several groups have attempted to identify predictors of concurrent or secondary BC associated with the discovery of an unusual lesion at biopsy. However, they are often focused on a subtype of atypia (eg atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia) and no prediction model has been validated in prospective multicenter. Based on a large retrospective study at Gustave Roussy, a prediction model (Nomat) has been developed, common to all atypical lesions, which can predict the presence of a BC at excision surgery (risk of concurrent BC). This model is based on the age of the patient, the disappearance of radiographic abnormalities (microcalcifications in general) after the biopsy and initial radiological lesion size. This model has good performance with an area under the curve (AUC) of 0.72. In previous series, with a BC high-risk threshold of 20%, negative predictive value was 90%, and this model would have prevented the surgery in 51% of patients (low risk patients by model). It is essential to validate this model by forward-looking and in different centers to ensure its relevance.
This is a multicenter prospective validation of the model on 300 patients operated for atypical lesions in 21 centers. All patients with atypical breast lesions have a routine surgery. The clinical data, imaging and histological data will be collected prospectively. The main objective of this study is to validate the model Nomat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with atypical lesions | Experimental | Procedure: Biopsy, Procedure: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women who have had a recent diagnosis of atypical breast lesions (atypical metaplasia, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ) on a breast biopsy for microcalcifications on mammography Or for little suspect distortion in ultrasound or mammary MRI.
- Report of the anatomopathological examination of the biopsy allowing the diagnosis of an atypical lesion available
- Patient 18 years or more
- Informed consent signed.
- Patient affiliated to a system of social security or beneficiary of such plan
Key exclusion criteria (10 listed)
- Nodular lesion associated with ultrasound or mammography opacity
- Palpable nodule
- Presence of ductal carcinoma in situ or invasive carcinoma associated to biopsy
- Personal history of breast cancer or homo contralateral
- Previous history of breast irradiation or breast cancer or other area for malignancy (Hodgkin, etc ...)
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 |
|---|---|---|
| Biopsy | Procedure or surgery | Patients with atypical lesions |
| Blood sample | Procedure or surgery | Patients with atypical lesions |
Primary outcome
Negative Predictive value of the NOMAT model
Time frame: Up to 3 months
The primary endpoint is the negative predictive value (NPV) of Nomat model used to predict the absence of breast cancer associated with cases of atypical lesions in breast biopsy
1 secondary outcome
Exploratory research for biomarkers using DNA Seq
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 32920723Uzan C, Mazouni C, Rossoni C, De Korvin B, de Lara CT, Cohen M, Chabbert N, Zilberman S, Boussion V, Vincent Salomon A, Espie M, Coutant C, Marchal F, Salviat F, Boulanger L, Doutriaux-Dumoulin I, Jouve E, Mathelin C, de Saint Hilaire P, Mollard J, Balleyguier C, Joyon N, Triki ML, Delaloge S, Michiels S. Prospective Multicenter Study Validate a Prediction Model for Surgery Uptake Among Women with Atypical Breast Lesions. Ann Surg Oncol. 2021 Apr;28(4):2138-2145. doi: 10.1245/s10434-020-09107-z. Epub 2020 Sep 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and Blood sample in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 10 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: finished, as of the sponsor's last update on 24 Jul 2018. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Negative Predictive value of the NOMAT model (time frame: Up to 3 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 NCT02523612, 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 24 Jul 2018.