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The primary objective: association study of characteristics of tumoral microenvironment and immunity of digestive cancers with patients' overall survival (OS).
The study aims to explore relationship between the molecular subgroups (DNA and RNA analysis), tumor microenvironment, host (immunity system, premetastatic niche, microbiota, metabolism) and survival (prognostic value), response (predictive value) and tolerance (toxicities) to conventional treatments or immunotherapies in digestive cancers, in particular, in colorectal cancer and pancreaticobiliary cancer.
This is a prognostic monocentric study which includes 2 parts:
The enrollment will last 10 years in Digestive Surgery Department, Ambroise Paré Hospital, APHP.
There is any change in management of patients' care who will participate to the study, all of the treatment modalities (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, intra-arterial treatments and supportive care) are possible and choice of treatment will be made by investigator physician, after multidisciplinary meeting validation, and according to referential and recommendations of practice in department.
Statistic analysis
The statistic analysis will be performed and reported according to the international guidelines STROBE for the observational studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Located/resected colorectal cancer | Active Comparator |
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| Advanced colorectal cancer | Active Comparator |
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| Located/resected pancreatic cancer | Active Comparator |
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| Advanced pancreatic cancer | Active Comparator |
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| Located/resected biliary tract cancer | Active Comparator |
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| Advanced biliary tract cancer | Active Comparator |
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| Located/resected gastroesophageal cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Following analysis should be performed with
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason). | monthly up to 3 months |
| Overall survival (OS) | The OS is defined as timeframe between beginning of treatment (date of surgery or 1st cure of chemotherapy/immunotherapy) and death (regardless of reason). | yearly up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival without disease (SWD) | The SWD is defined as timeframe between date of surgical treatment and appearance of cancer relapse, 2nd cancer diagnosis or death (regardless reason). | at month 1, 2 and 3, then yearly up to 10 years |
| Survival without progression (SWP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédérique PESCHAUD, MD, PhD | Contact | +33 1 49 09 53 35 | frederique.peschaud@aphp.fr | |
| Cindy NEUZILLET, MD | Contact | +33 1 47 11 15 15 | cindy.neuzillet@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frédérique PESCHAUD, MD, PhD | Digestive Surgery Department, Ambroise Paré Hospital, APHP | Principal Investigator |
| Cindy NEUZILLET, MD | Digestive Surgery Department, Ambroise Paré Hospital, APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Surgery Department, Ambroise Paré Hospital, APHP | Recruiting | Boulogne-Billancourt | 92100 | France |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System 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 |
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| Active Comparator |
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| Advanced gastroesophageal cancer | Active Comparator |
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| Located/resected neuroendocrine cancer | Active Comparator |
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| Advanced neuroendocrine cancer | Active Comparator |
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| Liver biopsy | Procedure | An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients. This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time. This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed. |
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| Stool collect | Biological | Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression). Analysis will be performed for microbiota and metabolism analysis. |
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The SWP is defined as timeframe between the beginning of treatment (date of 1st cure of chemotherapy/immunotherapy or date of 1st session of radiotherapy) and the 1st progression or death (regardless reason). The response of tumor will be evaluated according to the RECIST v1.1, Choi (intra-arterial treatments, antiangiogenic therapy) and/or iRECIST (immunotherapies) and/or imaging examinations depending on the given treatments. |
| at month 1, 2 and 3, then yearly up to 10 years |
| D005767 |
| Gastrointestinal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |