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
This trial does not accept healthy volunteersQualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 3 trial groupsGroup A: Cohort A : High grade serous ovarian carcinoma
Group B: Cohort B :Breast carcinoma SBR grade II or III
Group C: Cohort C : Extended Breast carcinoma In situ
Trial outcomes
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
Time frame
At surgerySecondary outcomes
1
Characterization of immune cells populations on blood sample
Frequency, phenotype and function/activation status of immune cells will be determined by flow cytometry and electrochemiluminescence
Time frame
At surgery2
Characterization of transcriptomic profile of immune cells populations
Biomarkers expression, activation or inhibition of functional pathways will be determined by transcriptome sequencing (RNAseq and single cell RNAseq) on tumor sample
Time frame
At surgery3
Characterization of molecular profile of tumor sample
Genes profile (Mutation, amplification, insertion, deletion) will be determined by whole exome sequencing (WES)
Time frame
At surgery4
Comparison of soluble factors of the tumor microenvironment with soluble factors present in the blood
Comparative characterization (nature and concentration) by Luminex technology MSD
Time frame
At surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Leon Berard
Lead sponsor
Cancer Research Center of Lyon
Collaborator
Source ClinicalTrials.gov