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

Not Applicable

• Conditions: Pancreatic Cancer
• Interventions: Other: Additional biological samples

• Registration Number: NCT02818907
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional biological samples	Additional biological samples	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.

Primary Outcome Measures

Name	Time	Method
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)	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

Trial Locations

Locations (8)

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire de Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire de Nancy; 🇫🇷 Nancy, France

Institut de cancérologie de Lorraine; 🇫🇷 Nancy, France

Centre Hospitalier Universitaire Robert Debré; 🇫🇷 Reims, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

CHU de Strasbourg - Hautepierre; 🇫🇷 Strasbourg, France