Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT02890095
Eligibility Criteria:
Inclusion Criteria:
1. Women ≥ 18 and \<75 years
2. According to the arm:
* Arm A: histologically confirmed diagnosis of invasive breast cancer (only), unilateral or bilateral, outside off recurrence and relapse. Patients who have been supported for a contralateral breast cancer can be included if a period of at least 2-years between the last systemic treatment of inclusion in the study.
* Arm B: Any woman operated on for breast plastic surgery (breast lift and breast reduction cure only)
3. Performance status (WHO) ≤ 1
5\. Patient affiliated to a social security scheme, 6. Patient who signed and dated informed consent form 7. Arm A only: unifocal lesion 8. Arm A only: Clinical stage M0
Exclusion Criteria:
1. Patient with uncontrolled infection
2. Patient pregnant or lactating
3. Patient with a viral infection (HIV, Hepatitis B, Hepatitis C)
4. Patient cannot be regularly monitored for psychological reasons, social, family or geographical.
5. Patient Private of liberty or under a guardianship authority / curatorship.
6. Arm A only: Patient to benefit from neoadjuvant therapy for breast cancer
7. Arm A only Patient with metastatic breast cancer
8. Arm A only Patient diagnosed cancer in situ (intra ductal)
9. Arm A only Patient with BRCA1 or BRCA2 known
10. Arm B only: previous breast plastic surgery, regardless of the type of intervention
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02890095
Study Brief:
Protocol Section:
NCT02890095