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

July 30, 2021 updated by: Centre Hospitalier Universitaire de Besançon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Besançon
        • Principal Investigator:
          • Bruno HEYD, Pr
      • Dijon, France
        • Recruiting
        • Centre Georges Francois Leclerc
      • Dijon, France
        • Recruiting
        • Centre Hospitalier Universitaire De Dijon
        • Contact:
          • Patrick RAT, Pr
        • Principal Investigator:
          • Patrick RAT, Pr
      • Nancy, France
        • Recruiting
        • Centre hospitalier universitaire de NANCY
        • Contact:
          • Ahmet AYAV, Pr
        • Principal Investigator:
          • Ahmet AYAV, Pr
      • Nancy, France
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Thierry CONROY, Pr
        • Principal Investigator:
          • Thierry CONROY, Pr
      • Reims, France
        • Recruiting
        • Centre Hospitalier universitaire Robert Debré
        • Contact:
          • Ali Reza KIANMANESH, Pr
        • Principal Investigator:
          • Ali Reza KIANMANESH, Pr
      • Strasbourg, France
        • Recruiting
        • Centre Paul Strauss
        • Contact:
          • Patrick DUFOUR, Pr
        • Principal Investigator:
          • Patrick DUFOUR, Pr
      • Strasbourg, France
        • Recruiting
        • CHU de Strasbourg - Hautepierre
        • Contact:
          • Philippe BACHELLIER, Pr
        • Principal Investigator:
          • Philippe BACHELLIER, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Other: Additional biological samples
blood and tumor tissue samples

What is the study measuring?

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)
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
date of first disease apparition [within 3 years after the enrollment of the last patient]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besançon

Collaborators

Cancéropôle Grand-Est

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pancreas-CGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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