Pancreatic AdenocarcinomaBACAPNCT02818829
Biological and Clinical Database for Pancreatic Adenocarcinoma
An observational study of Pancreatic Adenocarcinoma, run by University Hospital, Toulouse at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Collection of biological samples
- How many people
- 1,700 participants
- Where
- 16 sitesFrance
- Study dates
- May 2014to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment
Who may be able to join
- 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
Who cannot join
- no informed consent
- pregnancy women
- no histologically or cytologically confirmed pancreatic adenocarcinoma
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
University Hospital Bordeaux
Bordeaux, 33604
Beaujon Hospital
Clichy, 92110
University Hospital Lille
Lille, 59037
University Hospital of Lille
Lille, 59037
Centre Léon Bérard
Lyon, 69008
Private Hospital Jean Mermoz
Lyon, 69008
Hopital La Timone
Marseille, 13000
Hospital Nord
Marseille, 13000
Institut Regional du Cancer de Montpellier
Montpellier, 34000
University Hospital Montpellier
Montpellier, 34000
University Hospital of NICE
Nice, 06202
Saint-Louis Hospital
Paris, 75010
Clinique du Trocadero
Paris, 75016
Pau Hospital
Pau, 64000
University Hospital Toulouse
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
About this study
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
Read the 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.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Collection of biological samples
- Keywords
- Adenocarcinoma, Endoscopic ultrasonography, Fine-needle aspiration, Biomarkers, Epidemiology, DNA tumors
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesOther
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 group | Role | What they receive |
|---|---|---|
| Cohort | Collection of biological samples Receives: Other: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constitution of a transdisciplinary biobank with collection of biological samples with DNA
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
Measured: Through the study completion, an average of 11 months
Constitution of a transdisciplinary biobank with collection of biological samples without DNA
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
Measured: Through the study completion, an average of 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startMay 2014
- Primary completion10 Nov 2023
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara BOURNET, MD; PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818829
- Sponsor's protocol ID
- 13 038 07
- Acronym
- BACAP
- Status last verified
- Mar 2025
- First submitted
- 20 Jun 2016
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32218346Frere 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.
PubMed 31843588Canivet 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.
PubMed 30326968
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Clinical Database for Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02818829
- Acronym / sponsor ID
- BACAP / 13 038 07
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Adenocarcinoma, Endoscopic ultrasonography, Fine-needle aspiration, Biomarkers, Epidemiology, DNA tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: Collection of biological samplesCollection of biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a pancreatic adenocarcinoma proven cytologically or histologically without any treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- no informed consent
- pregnancy women
- no histologically or cytologically confirmed pancreatic adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological samplesCollection 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 | Other | Cohort |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 32218346Maulat 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.
- Derived from this study: PubMed 31843588Frere 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.
- Derived from this study: PubMed 30326968Canivet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara BOURNET, MD; PHD principal investigator
University Hospital, Toulouse
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma, run by University Hospital, Toulouse at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution of a transdisciplinary biobank with collection of biological samples with DNA (time frame: Through the study completion, an average of 11 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.