Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Leon Berard
About this trial
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 criteria
Qualifiers
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).
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsSponsors and collaborators
Centre Leon Berard
Lead sponsor
Cancer Research Center of Lyon
Collaborator
Source ClinicalTrials.gov