Biological and Clinical Database for Pancreatic Adenocarcinoma (BACAP)
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| ClinicalTrials.gov Identifier: NCT02818829 |
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Recruitment Status : Unknown
Verified July 2020 by University Hospital, Toulouse.
Recruitment status was: Recruiting
First Posted : June 30, 2016
Last Update Posted : July 30, 2020
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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 |
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 |
| 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 |
|---|---|
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Cohort
Collection of biological samples
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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 |
- 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
Biospecimen Retention: Samples With DNA
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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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Barbara BOURNET, MD; PHD | University Hospital, Toulouse |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Adenocarcinoma Endoscopic ultrasonography Fine-needle aspiration |
Biomarkers Epidemiology DNA tumors |
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |