Biological and Clinical Database for Pancreatic Adenocarcinoma (BACAP)

March 18, 2025 updated by: University Hospital, Toulouse

BACAP is a biobank dedicated to the pancreatic adenocarcinoma funded by institut national institue du cancer (INCa) and coordinated by Dr Barbara Bournet from Toulouse hospital. This base includes clinical data and biological samples such as blood, serum, plasma, saliva, DNA and RNA from tumors cells.

The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic cancer represents the fifth cause of death by cancer in Western countries. In over 90% of cases, it is due to an adenocarcinoma. The only curative treatment for pancreatic cancer remains the surgical exeresis. This one can only be suggested as a curative treatment in only 10 to 15% of cases. Besides, prevention or screening is impossible due to the absence of clearly identified risk factors or groups and to the absence of useful markers for the diagnosis in clinical practice.

The research efforts in this area must face a double challenge: saving time while improving the diagnosis period and strengthen the therapeutic equipment. It is important to identify and characterise the new molecular markers applicable for a better diagnosis and/or treatment (especially the response factors to chemotherapy). The present project aims at creating a multicentre national network used to set up a clinical biological base (CBB) dedicated to the pancreatic adenocarcinoma, built on the best quality standards, for the biological resources as well as the associated clinical and epidemiological data.

The originality of this CBB relies on the fact that it will have not only tumour tissues sampled from surgical specimens of resectable tumours but also cell and biopsy material from unresectable and/or metastatic tumours sampled under endoscopic ultrasonography (1500 biopsies over 3 years coupled to systematic blood samples). Endoscopic ultrasonography is a technique used to specifically perform biopsies on pancreatic tumours and to obtain useful cell material for research. To these samples will be associated every clinical and epidemiological target data required for research projects related to this unique CBB in France. From these samples, DNA and RNA will be especially isolated, as it is a precious biological material for the programmed molecular analyses.

There are many stakes: creating a French network in order to form, with the prospective plans over 3 years, a collection of tissue, biopsies, nucleic acids from pancreatic cancer associated to circulating blood samples and relevant clinical data. Thanks to this collection, the investigator team hope to be able to identify new molecular markers (from cancer tissue and/or circulating blood from pancreatic cancer patients) applicable to clinical practice to diagnose, to assess the prognosis or to predict the response to pancreatic cancer chemotherapy. The investigator team will also try to identify new risk factors for this cancer, especially regarding the diet. The base will thus be made up from 12 different French centres from University Hospital and private Centres where gastroenterologists, oncologists, digestive surgeons, anatomopathologists, epidemiologists intervene as they are all associated to scientific teams dedicated to pancreatic cancer, itself already formed in collaborative networks.

Investigators hope through this project: to get a unique and exceptional CBB for pancreatic cancer, to reach the required standards (especially Inca) for this CBB, and to be internationally recognised. This base will be a strong guarantee to identify new molecular markers for the diagnosis, the prognosis, and the predictive response to chemotherapy for pancreatic cancer, especially when locally advanced. Finally, the epidemiological projects related to this project are originally about the nutritional issues (regardless of the lipid diet and the cachexia) associated to pancreatic cancer.

Study Type

Observational

Enrollment (Actual)

1700

Contacts and Locations

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

Study Locations

  • France
      • Bordeaux, France, 33604
        • University Hospital Bordeaux
      • Clichy La Garenne, France, 92110
        • Beaujon Hospital
      • Lille, France, 59037
        • University Hospital of Lille
      • Lille, France, 59037
        • University Hospital Lille
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Lyon, France, 69008
        • Private Hospital Jean Mermoz
      • Marseille, France, 13000
        • Hôpital la Timone
      • Marseille, France, 13000
        • Hospital Nord
      • Montpellier, France, 34000
        • University Hospital Montpellier
      • Montpellier, France, 34000
        • Institut régional du Cancer de Montpellier
      • Nice, France, 06202
        • University Hospital of Nice
      • Paris, France, 75010
        • Saint-Louis Hospital
      • Paris, France, 75016
        • Clinique du Trocadero
      • Pau, France, 64000
        • Pau Hospital
      • Toulouse, France, 31059
        • University Hospital Toulouse
      • Villejuif, France, 94805
        • Institut Gustave Roussy

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

Sampling Method

Non-Probability Sample

Study Population

Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment

Description

Inclusion Criteria:

  • Patient eighteen years old
  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Solid pancreatic mass explored with tomodensitometry or endoscopic ultrasonography fine-needle aspiration
  • Informed consent signed

Exclusion Criteria:

  • no informed consent
  • pregnancy women
  • no histologically or cytologically confirmed pancreatic adenocarcinoma

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Collection of biological samples
Other: Collection of biological samples
Collection of biological samples including whole blood, serum, plasma, saliva, DNA and RNA from tumor cells, tissue from tumor biopsies, tissue from tumor and adjacent tissue of pancreas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constitution of a transdisciplinary biobank with collection of biological samples with DNA
Time Frame: Through the study completion, an average of 11 months
The present project aims at creating, coordinating, animating a transdisciplinary multicentric national network, used to set up a clinical biological base (CBB) dedicated to the pancreatic adenocarcinoma
Through the study completion, an average of 11 months
Constitution of a transdisciplinary biobank with collection of biological samples without DNA
Time Frame: Through the study completion, an average of 11 months
The present project aims at creating, coordinating, animating a transdisciplinary multicentric national network, used to set up a clinical biological base (CBB) dedicated to the pancreatic adenocarcinoma
Through the study completion, an average of 11 months

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Barbara BOURNET, MD; PHD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

May 1, 2014

Primary Completion (Actual)

November 10, 2023

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 038 07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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