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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

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


Condition or disease Intervention/treatment
Pancreatic Adenocarcinoma Other: Collection of biological samples

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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biological and Clinical Database for Pancreatic Adenocarcinoma
Study Start Date : March 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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




Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, saliva, DNA and RNA from tumor cells, tissue from tumor biopsie, tissue from tumor and adjacent tissue of pancreas


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment
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

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): NCT02818829


Contacts
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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

Locations
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France
University Hospital Bordeaux Recruiting
Bordeaux, France, 33604
Contact: Véronique VENDRELY., MD       veronique.vendrely@chu-bordeaux.fr   
Beaujon Hospital Recruiting
Clichy La Garenne, France, 92110
Contact: Pascal HAMMEL, MD; PHD       pascal.hammel@aphp.fr   
University Hospital Lille Recruiting
Lille, France, 59037
Contact: Stéphanie TRUANT, MD; PHD       Stephanie.TRUANT@CHRU-LILLE.FR   
University Hospital of Lille Recruiting
Lille, France, 59037
Contact: Guillaume PIESSEN, MD; PHD       Guillaume.PIESSEN@CHRU-LILLE.FR   
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Pierre GUIBERT, MD       Pierre.GUIBERT@lyon.unicancer.fr   
Private Hospital Jean Mermoz Recruiting
Lyon, France, 69008
Contact: Bertrand NAPOLEON       bertrand.napoleon@dartybox.com   
Hopital La Timone Recruiting
Marseille, France, 13000
Contact: Jean-François SEITZ, MD; PHD       Jean-francois.SEITZ@ap-hm.fr   
Hospital Nord Recruiting
Marseille, France, 13000
Contact: Stéphane GARCIA       Stephane.GARCIA@ap-hm.fr   
Institut Regional du Cancer de Montpellier Recruiting
Montpellier, France, 34000
Contact: Fréderic BIBEAU, MD; PHD       Frederic.Bibeau@icm.unicancer.fr   
University Hospital Montpellier Recruiting
Montpellier, France, 34000
Contact: Eric ASSENAT, MD, PHD       e-assenat@chu-montpellier.fr   
University Hospital of NICE Recruiting
Nice, France, 06202
Contact: Geoffroy VANBIERVLIET, MD; PHD       vanbiervliet.g@chu-nice.fr   
Saint-Louis Hospital Recruiting
Paris, France, 75010
Contact: Dominique FARGE-BANCEL, MD, PHD       dominique.farge-bancel@aphp.fr   
Clinique du Trocadero Recruiting
Paris, France, 75016
Contact: Laurent PALAZZO, MD       laurent.palazzo@wanadoo.fr   
Pau Hospital Recruiting
Pau, France, 64000
Contact: Philippe BERTHELEMY, MD       philippe.berthelemy@ch-pau.fr   
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Louis BUSCAIL, MD; PHD       buscail.l@chu-toulouse.fr   
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Jean-Yves SCOAZEC, MD; PHD       Jean-yves.SCOAZEC@gustaveroussy.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Barbara BOURNET, MD; PHD University Hospital, Toulouse
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02818829    
Other Study ID Numbers: 13 038 07
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Toulouse:
Adenocarcinoma
Endoscopic ultrasonography
Fine-needle aspiration
Biomarkers
Epidemiology
DNA tumors
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms