RecruitingNCT04562623

Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

Sponsor

Centre Leon Berard

Enrollment

160 participants

Start Date

Jul 1, 2021

Study Type

OBSERVATIONAL

Conditions

Breast Carcinoma Ovarian Carcinoma

Summary

GYNECO-IMM\&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

I1. Female patients aged ≥ 18 tears at time of inform consent signature.
I2. Patient with planned primitive tumor surgery listed below : High grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III \> 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).
Note : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized.
I3. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply procedures required per protocol.
I4. Patient must be covered by a medical insurance.

Exclusion Criteria7

E1. Patient under guardianship or trusteeship.
E2. Cancer with constitutional BRCA1/2 mutation.
E3. Previously treated by immunomodulators (PD1/PDL1, CTLA4).
E4. Systemic treatment by an immunosuppressor (including, but not limited to, corticosteroids, azathioprine, methotrexate, thalidomide and anti-TNF-alpha) or by an immunostimulant within 2 weeks before inclusion, except corticosteroids listed below: inhaled corticosteroids, intranasal corticosteroids, topic corticosteroids, and systemic corticosteroids with prednisone or equivalent physiological dose ≤ 10 mg/day.
E5. Patient with known history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis,systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipids syndrome, Wegener syndrome , Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vascularitis, or glomerulonephritis, B or C hepatitis infection, HIV infection.
E6. Patient with other active tumor except if the tumor is considered not to interfere with outcome measures following sponsor approval such as basal or squamous cell skin cancer. Patient previously treated for an other cancer and without relapse for at least one year are eligible.
E7. Pregnant or breastfeeding woman.