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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818907
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
Cancéropôle Grand-Est
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Other: Additional biological samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort
Study Start Date : May 2016
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818907


Contacts
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Contact: Bruno HEYD, Pr bruno.heyd@univ-fcomte.fr
Contact: Christophe BORG, Pr christophe.borg@efs.sante.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besançon, France, 25000
Contact: Christophe BORG, Pr       christophe.borg@efs.sante.fr   
Principal Investigator: Bruno HEYD, Pr         
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: François GHIRINGHELLI, Pr         
Principal Investigator: François GHIRINGHELLI, Pr         
Centre Hospitalier Universitaire de Dijon Recruiting
Dijon, France
Contact: Patrick RAT, Pr         
Principal Investigator: Patrick RAT, Pr         
Principal Investigator: Sylvain MANFREDI, Pr         
Centre Hospitalier Universitaire de Nancy Recruiting
Nancy, France
Contact: Ahmet AYAV, Pr         
Principal Investigator: Ahmet AYAV, Pr         
Institut de cancérologie de Lorraine Not yet recruiting
Nancy, France
Contact: Thierry CONROY, Pr         
Principal Investigator: Thierry CONROY, Pr         
Centre Hospitalier Universitaire Robert Debré Recruiting
Reims, France
Contact: Ali Reza KIANMANESH, Pr         
Principal Investigator: Ali Reza KIANMANESH, Pr         
Centre Paul Strauss Recruiting
Strasbourg, France
Contact: Patrick DUFOUR, Pr         
Principal Investigator: Patrick DUFOUR, Pr         
CHU de Strasbourg - Hautepierre Recruiting
Strasbourg, France
Contact: Philippe BACHELLIER, Pr         
Principal Investigator: Philippe BACHELLIER, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Cancéropôle Grand-Est
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02818907    
Other Study ID Numbers: Pancreas-CGE
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases