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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional biological samples
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Régional Universitaire de BesançonRecruiting
  • Centre Georges François LeclercRecruiting
  • Centre Hospitalier Universitaire de DijonRecruiting
  • Centre Hospitalier Universitaire de NancyRecruiting
  • Institut de cancérologie de Lorraine
  • Centre Hospitalier Universitaire Robert DebréRecruiting
  • Centre Paul StraussRecruiting
  • CHU de Strasbourg - HautepierreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Additional biological samples

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2016
Last Updated
July 30, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Cancéropôle Grand-Est
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1. Study Identification

Unique Protocol Identification Number
NCT02818907
Brief Title
Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable
Acronym
Pancreas-CGE
Official Title
Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Cancéropôle Grand-Est

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional biological samples
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Additional biological samples
Intervention Description
blood and tumor tissue samples
Primary Outcome Measure Information:
Title
disease-free survival according to the consensus DATECAN (Bonnetain F et al, European Journal of Cancer 2014)
Description
DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials
Time Frame
date of first disease apparition [within 3 years after the enrollment of the last patient]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno HEYD, Pr
Email
bruno.heyd@univ-fcomte.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe BORG, Pr
Email
christophe.borg@efs.sante.fr
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BORG, Pr
Email
christophe.borg@efs.sante.fr
First Name & Middle Initial & Last Name & Degree
Bruno HEYD, Pr
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GHIRINGHELLI, Pr
First Name & Middle Initial & Last Name & Degree
François GHIRINGHELLI, Pr
Facility Name
Centre Hospitalier Universitaire de Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick RAT, Pr
First Name & Middle Initial & Last Name & Degree
Patrick RAT, Pr
First Name & Middle Initial & Last Name & Degree
Sylvain MANFREDI, Pr
Facility Name
Centre Hospitalier Universitaire de Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet AYAV, Pr
First Name & Middle Initial & Last Name & Degree
Ahmet AYAV, Pr
Facility Name
Institut de cancérologie de Lorraine
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry CONROY, Pr
First Name & Middle Initial & Last Name & Degree
Thierry CONROY, Pr
Facility Name
Centre Hospitalier Universitaire Robert Debré
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Reza KIANMANESH, Pr
First Name & Middle Initial & Last Name & Degree
Ali Reza KIANMANESH, Pr
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick DUFOUR, Pr
First Name & Middle Initial & Last Name & Degree
Patrick DUFOUR, Pr
Facility Name
CHU de Strasbourg - Hautepierre
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe BACHELLIER, Pr
First Name & Middle Initial & Last Name & Degree
Philippe BACHELLIER, Pr

12. IPD Sharing Statement

Learn more about this trial

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

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