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

NCT02818907 | Completed

• 1 other identifier: Pancreas-CGE
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 8

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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]

Study Arms (1)

Additional biological samples

OTHER

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

Interventions

Additional biological samples OTHER

blood and tumor tissue samples

Additional biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Cancéropôle Grand-Est: collaborator

Study Sites (8)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25000, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, France

Location

Institut de cancérologie de Lorraine

Nancy, France

Location

Centre Hospitalier Universitaire Robert Debré

Reims, France

Location

Centre Paul Strauss

Strasbourg, France

Location

CHU de Strasbourg - Hautepierre

Strasbourg, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: May 19, 2016
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (8)