Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma (GYNECO-IMM&CO)

February 9, 2024 updated by: Centre Leon Berard
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Breast cancer is the main cancer in women and is the second cause of mortality by cancer in the world for women ; high grade serous ovarian cancer is a rare pathology but survival is less 25% at 5 years.

Breast and ovarian cancers are complex entities with heterogeneous tumor cells but also normal cells including immune cells with represent the microenvironment of the tumor.This microenvironment limits tumor progression but also has been shown to play a crucial role in disease progression, tumor angiogenesis, maintenance and resistance to anticancer therapies.

Despite newly developed immunotherapies, only one-third of patients with breast and ovarian cancer responds to checkpoint inhibitors ; so today there is poor benefit to treat breast and ovarian cancers with immunotherapies. Therefore it needs to better understand immune mechanisms which reduce treatment efficacy. The aim of this clinical study is to better understand mechanisms of immune response inhibition in breast and ovarian cancers. It would characterize actionable targets in patients with resistance to conventional anticancer treatments or immunotherapies.In this context, the hypothesis is that some specific phenotypical or functional alterations of specific immune cells populations (DC, LB, plasmocytes IgA, neutrophils, NK cells, CD8+CD39+ LT, Treg) induce tumoral progression in breast and ovarian cancer. These immune populations will be described (qualitative, quantitative and functional descriptions ; proteic, transcriptomic and genomic profiles) in order to i) determine new immune surveillance mechanisms ii) new targets which allow efficient antitumoral immunity in breast and ovarian cancers.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of immune cells populations on tumour sample from exeresis
Time Frame: At surgery
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry, electrochemiluminescence and proliferation test
At surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of immune cells populations on blood sample
Time Frame: At surgery
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry and electrochemiluminescence
At surgery
Characterization of transcriptomic profile of immune cells populations
Time Frame: At surgery
Biomarkers expression, activation or inhibition of functional pathways will be determined by transcriptome sequencing (RNAseq and single cell RNAseq) on tumor sample
At surgery
Characterization of molecular profile of tumor sample
Time Frame: At surgery
Genes profile (Mutation, amplification, insertion, deletion) will be determined by whole exome sequencing (WES)
At surgery
Comparison of soluble factors of the tumor microenvironment with soluble factors present in the blood
Time Frame: At surgery
Comparative characterization (nature and concentration) by Luminex technology MSD
At surgery
Characterization of immunoglobulins and their antigenic targets
Time Frame: At surgery
Characterization by Elisa and Luminex
At surgery
Characterization of TCR repertory of LT CD8+ and Tregs
Time Frame: At surgery
TCR repertory of LT CD8+ and Tregs will be determined by transcriptomic profile by RNAseq
At surgery
Determination of the correlation between biological characterizations at surgery and clinical characterizations
Time Frame: Up to 60 months
Clinical characterizations are consistent with treatment response and survival ; biological characteristics will describe molecular and transcriptomic profile of the tumor.
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Centre de Recherche en Cancérologie de Lyon (CRCL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET19-283

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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