Clinical trial NCT02818829: Biological and Clinical Database for Pancreatic Adenocarcinoma
Official title: Biological and Clinical Database for Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Adenocarcinoma
Keywords: Adenocarcinoma
Endoscopic ultrasonography
Fine-needle aspiration
Biomarkers
Epidemiology
DNA tumors
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment

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.

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

Primary outcomes:
measure: Constitution of a transdisciplinary biobank with collection of biological samples with DNA
timeFrame: Through the study completion, an average of 11 months
measure: Constitution of a transdisciplinary biobank with collection of biological samples without DNA
timeFrame: Through the study completion, an average of 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Clichy La Garenne
country: France
facility: Beaujon Hospital
city: Lille
country: France
facility: University Hospital Lille
city: Lille
country: France
facility: University Hospital of Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Private Hospital Jean Mermoz
city: Marseille
country: France
facility: Hopital La Timone
city: Marseille
country: France
facility: Hospital Nord
city: Montpellier
country: France
facility: Institut Regional du Cancer de Montpellier
city: Montpellier
country: France
facility: University Hospital Montpellier
city: Nice
country: France
facility: University Hospital of NICE
city: Paris
country: France
facility: Saint-Louis Hospital
city: Paris
country: France
facility: Clinique du Trocadero
city: Pau
country: France
facility: Pau Hospital
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: University Hospital, Toulouse
name: Barbara BOURNET, MD; PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.