Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable

Study Overview
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Brief Summary
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This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.

Official Title
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Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: Additional biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with exocrine resectable pancreatic adenocarcinoma or potentially resectable (that after neoadjuvant treatment are considered appropriate candidates for resection) Histologically or cytologically documented diagnosis of exocrine pancreatic adenocarcinoma Written informed consent obtained prior enrollment in the study Exclusion Criteria: other types of pancreatic cancer, in particular endocrine tumor or acinar cells ampulloma metastatic disease other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study patient under guardianship, curator or under the protection of justice.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Additional biological samples<br>Additional blood samples will be realized specifically to the study at baseline, after neoadjuvant chemotherapy (if applicable) and before surgery, 1 month after surgery and 1 month after the last adjuvant chemotherapy cycle. Peripheral blood mononuclear cell (PBMC), plasma and circulating tumor DNA and RNA will be collected. Tumor tissue will be collected during surgery. | Other: Additional biological samples<br>* blood and tumor tissue samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014) | DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials | date of first disease apparition [within 3 years after the enrollment of the last patient] |