NCT04562623Recruiting
Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 18 Sept 2020
- Start date
- 1 Jul 2021
- Primary completion date
- Jul 2026
- Lead sponsor
- Centre Leon Berard
- Diseases
- Ovarian cancer
- NCT number
- NCT04562623
What you commit to
- Study type: Observational
- Planned participants: 160
- From 1 Jul 2021 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- E2. Cancer with constitutional BRCA1/2 mutation.
- 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.
Other
- E1. Patient under guardianship or trusteeship.
- E7. Pregnant or breastfeeding woman.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.