Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable (Pancreas-CGE)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Other: Additional biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02818907

Pancreas-CGE

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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290 participants in 1 patient group

Additional biological samples

Other group

Description:

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.

Treatment:

Other: Additional biological samples