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| Name | Class |
|---|---|
| Cancer Research Center of Lyon | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At surgery |
| Characterization of transcriptomic profile of immune cells populations |
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Inclusion Criteria:
Note : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized.
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Recruiting | Lyon | France | 69008 | France |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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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)
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 | 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 | Comparative characterization (nature and concentration) by Luminex technology MSD | At surgery |
| Characterization of immunoglobulins and their antigenic targets | Characterization by Elisa and Luminex | At surgery |
| Characterization of TCR repertory of LT CD8+ and Tregs | 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 | Clinical characterizations are consistent with treatment response and survival ; biological characteristics will describe molecular and transcriptomic profile of the tumor. | Up to 60 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |