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Biological and Clinical Database for Pancreatic Adenocarcinoma (BACAP)

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ClinicalTrials.gov Identifier: NCT02818829
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 30, 2016
Last Update Posted Date July 30, 2020
Study Start Date March 2014
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2016)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biological and Clinical Database for Pancreatic Adenocarcinoma
Official Title Biological and Clinical Database for Pancreatic Adenocarcinoma
Brief Summary

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

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, plasma, saliva, DNA and RNA from tumor cells, tissue from tumor biopsie, tissue from tumor and adjacent tissue of pancreas
Sampling Method Non-Probability Sample
Study Population Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment
Condition Pancreatic Adenocarcinoma
Intervention 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
Study Groups/Cohorts Cohort
Collection of biological samples
Intervention: Other: Collection of biological samples
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2016)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Barbara BOURNET, MD; PHD 5 61 32 32 35 ext +33 bournet.b@chu-toulouse.fr
Contact: Cindy CANIVET, PHD 5 61 32 20 48 ext +33 canivet.c@chu-toulouse.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02818829
Other Study ID Numbers 13 038 07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Toulouse
Study Sponsor University Hospital, Toulouse
Collaborators Not Provided
Investigators
Principal Investigator: Barbara BOURNET, MD; PHD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date July 2020