Actively Recruiting

Age: 18Years +
FEMALE
NCT04562623

Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

Led by Centre Leon Berard · Updated on 2026-04-27

160

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

C

Centre Leon Berard

Lead Sponsor

C

Cancer Research Center of Lyon

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older at the time of informed consent.
  • Patients scheduled for primary tumor surgery for either high grade serous ovarian carcinoma, breast carcinoma grade II or III larger than 3 cm, or extensive breast carcinoma in situ with invasive nodule eligible for mastectomy.
  • Patients who understand and sign the written informed consent and agree to follow study procedures.
  • Patients must have medical insurance coverage.
Not Eligible

You will not qualify if you...

  • Patients under legal guardianship or trusteeship.
  • Patients with cancer linked to constitutional BRCA1/2 mutations.
  • Patients previously treated with immunomodulators such as PD1/PDL1 or CTLA4 inhibitors.
  • Patients receiving systemic immunosuppressive treatments or immunostimulants within 2 weeks before inclusion, except certain low-dose corticosteroids and topical forms.
  • Patients with known autoimmune diseases including myasthenia gravis, myositis, autoimmune hepatitis, lupus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis with antiphospholipid syndrome, Wegener syndrome, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, hepatitis B or C, or HIV infection.
  • Patients with other active tumors unless approved by the sponsor and considered not to interfere with study outcomes.
  • Pregnant or breastfeeding women.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Léon Bérard

Lyon, France, France, 69008

Actively Recruiting

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Research Team

N

Nicolas Chopin

CONTACT

C

Christophe Caux

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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