Biological and Clinical Database for Pancreatic Adenocarcinoma
NCT ID: NCT02818829
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1700 participants
OBSERVATIONAL
2014-05-31
2029-01-31
Brief Summary
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The mission of this prospective project is to make available to the scientific community a clinical biological base from patients with pancreatic adenocarcinoma
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Collection of biological samples
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Solid pancreatic mass explored with tomodensitometry or endoscopic ultrasonography fine-needle aspiration
* Informed consent signed
Exclusion Criteria
* pregnancy women
* no histologically or cytologically confirmed pancreatic adenocarcinoma
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Barbara BOURNET, MD; PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Bordeaux
Bordeaux, , France
Beaujon Hospital
Clichy, , France
University Hospital Lille
Lille, , France
University Hospital of Lille
Lille, , France
Centre Léon Bérard
Lyon, , France
Private Hospital Jean Mermoz
Lyon, , France
Hopital La Timone
Marseille, , France
Hospital Nord
Marseille, , France
Institut Regional du Cancer de Montpellier
Montpellier, , France
University Hospital Montpellier
Montpellier, , France
University Hospital of NICE
Nice, , France
Saint-Louis Hospital
Paris, , France
Clinique du Trocadero
Paris, , France
Pau Hospital
Pau, , France
University Hospital Toulouse
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Maulat C, Canivet C, Touraine C, Gourgou S, Napoleon B, Palazzo L, Flori N, Piessen G, Guibert P, Truant S, Assenat E, Buscail L, Bournet B, Muscari F, The Bacap Consortium. A New Score to Predict the Resectability of Pancreatic Adenocarcinoma: The BACAP Score. Cancers (Basel). 2020 Mar 25;12(4):783. doi: 10.3390/cancers12040783.
Frere C, Bournet B, Gourgou S, Fraisse J, Canivet C, Connors JM, Buscail L, Farge D; BACAP Consortium. Incidence of Venous Thromboembolism in Patients With Newly Diagnosed Pancreatic Cancer and Factors Associated With Outcomes. Gastroenterology. 2020 Apr;158(5):1346-1358.e4. doi: 10.1053/j.gastro.2019.12.009. Epub 2019 Dec 14.
Canivet C, Gourgou-Bourgade S, Napoleon B, Palazzo L, Flori N, Guibert P, Piessen G, Farges-Bancel D, Seitz JF, Assenat E, Vendrely V, Truant S, Vanbiervliet G, Berthelemy P, Garcia S, Gomez-Brouchet A, Buscail L, Bournet B; BACAP Consortium. A prospective clinical and biological database for pancreatic adenocarcinoma: the BACAP cohort. BMC Cancer. 2018 Oct 16;18(1):986. doi: 10.1186/s12885-018-4906-4.
Other Identifiers
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13 038 07
Identifier Type: -
Identifier Source: org_study_id
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