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The immune system may be involved in the recognition and destruction of tumor cells or cells undergoing transformation. It is also currently accepted that the quality of immune responses can influence the evolution of cancers after chemotherapy.
In this context, it is possible to assess the presence of specific T cells in patients' blood and to correlate the presence of specific memory lymphocytes with the quality of long-term clinical protection.
The analysis of immune responses can also be based on i) analysis of the tumor microenvironment (analysis of surgical samples or biopsies) or ii) analysis of molecules secreted in plasma.
Today, the immunotherapies can generate clinical responses in several cancers (for 15 to 25% of patients with melanomas, bladder, lung, kidney or gastric cancers). But the development of these drugs raises two unresolved questions: i) what immunological parameters predict the efficacy of these treatments? ii) why do some cancers remain refractory to the efficacy of these immunomodulatory drugs? It is therefore necessary to identify biomarkers for prognostic stratification and monitoring of patients treated by immunotherapy.
The primary objective of our research team is to identify biomarkers related to the immune system or tumor microenvironment in order to better define patient eligibility criteria for immunotherapy strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood test | Experimental | In cohort A: patients with advanced digestive or gynecological cancers eligible to immunotherapies. In cohort B: patients with advanced digestive or gynecological cancers eligible to treatment without immunotherapy. In cohort C: patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Diagnostic Test | In cohort A: 3 or 4 blood samples (for plasma and PBMC collection) : at baseline (before immunotherapy initiation); at 3 months ; at 12 months; on case of severe or unexpected toxicity. In cohort B: 3 blood sampes (for plasma and PBMC collection): at baseline (before treatment initiation); at 3 months ; at 12 months In cohort C: 2 blood samples (for plasma and PBMC collection) : at baseline (at the time of surgery); at 3 months (after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation | Progression free survival (PFS) at 6 months post treatment initiation, defined as:
| 6 months post treatment initiation |
| For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases | RFS: defined as the delay from the date of surgery of metastases to the disease relapse or death from any cause whichever occurs first. Alive patient without relapse will be censored at last radiological evaluation available showing no relapse. | 6 months after surgery of metastases |
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INCLUSION CRITERIA:
General inclusion criteria:
Specific eligibility criteria:
- Cohort A [Patients with advanced digestive or gynecological cancers eligible to immunotherapies]: Patients with locally advanced or metastatic digestive or gynecological cancers A1: hepatocellular carcinoma eligible to immunotherapy ± antiangiogenic A2: biliary tract carcinoma eligible to chemo-immunotherapy A3: oesogastric carcinoma eligible to chemo-immunotherapy A4: other digestive localizations eligible to immunotherapy (anti-PD1/PDL1 ± anti-CTLA4) ± chemotherapy A5: gynecological cancers eligible to chemo-immunotherapy
- Cohort B [Patients with advanced digestive or gynecological cancers eligible to chemotherapy or targeted therapy without immunotherapy]: Patients with locally advanced or metastatic digestive or gynecological cancers B1: hepatocellular carcinoma eligible to antiangiogenic or chemotherapy B2: biliary tract carcinoma eligible to chemotherapy B3: oesogastric carcinoma eligible to chemotherapy B4: other digestive localizations eligible to chemotherapy and/or targeted therapy B5: gynecological cancers eligible to chemotherapy and/or targeted therapy
- Cohort C [Patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy]: Patients with liver metastasis of colorectal cancer or peritoneal metastasis of ovarian cancer eligible to surgical resection
EXCLUSION CRITERIA :
General exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe BORG, PU-PH | Contact | +33(0)381668166 | xtoph.borg@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Besançon | Recruiting | Besançon | 25000 | France |
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|
| Tumor tissue | Other | Cohort A and B: 1 tumor block in paraffin at diagnosis + 1 tumor block in paraffin at progression (optional) Cohort C: Fresh tumoral tissue fragments for TIL and CAF + 1 tumor block in paraffin at time of surgery. |
|
| Georges François Leclerc center | Not yet recruiting | Dijon | 21000 | France |
|
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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