Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 350
- Locations
- 8
- Primary Endpoint
- disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
Time Frame: date of first disease apparition [within 3 years after the enrollment of the last patient]
DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials