Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

NCT04562623 | Recruiting

• 1 other identifier: ET19-283
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Carcinoma; Breast Carcinoma

Keywords

Ovarian cancer; Breast cancer; Immune alterations; Predictive biomarkers

Outcome Measures

Primary Outcomes (1)

• Characterization of immune cells populations on tumour sample from exeresis

  Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry, electrochemiluminescence and proliferation test

  At surgery

Secondary Outcomes (7)

• Characterization of immune cells populations on blood sample

  At surgery

• Characterization of transcriptomic profile of immune cells populations

  At surgery

• Characterization of molecular profile of tumor sample

  At surgery

• Comparison of soluble factors of the tumor microenvironment with soluble factors present in the blood

  At surgery

• Characterization of immunoglobulins and their antigenic targets

  At surgery

Study Arms (3)

Cohort A : High grade serous ovarian carcinoma

Cohort B :Breast carcinoma SBR grade II or III

Breast carcinoma SBR grade II or III superior to 3 cm

Cohort C : Extended Breast carcinoma In situ

Extended Breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with operable ovarian or breast cancer : patients with 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).

You may qualify if:

• 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.

You may not qualify if:

• E1. Patient under guardianship or trusteeship.
• E2. Cancer with constitutional BRCA1/2 mutation.
• E3. Previously treated by immunomodulators (PD1/PDL1, CTLA4).
• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead
• Cancer Research Center of Lyon: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, France, 69008, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples : FFPE and fresh samples (Fragment of surgery specimen, mastectomy) ; Blood samples (total blood (plasma isolation, circulating DNA, circulating RNA, constitutional DNA and PBMC) and serum)

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nicolas Chopin

CONTACT

+ 33 (0)4 78 78 28 28; nicolas.chopin@lyon.unicancer.fr

Christophe Caux

CONTACT

+ 33 (0)4 78 78 27 50; Christophe.caux@lyon.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: July 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)