Digestive CancerBCBInstitutNCT03449264
Development of Clinical and Biological Database
A study testing biological collection in people with Digestive Cancer and Gynecologic Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The BCB is a tool: for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials; to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancer, Gynecologic Cancer, Breast Cancer
- What is being tested?
- biological collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2017to Nov 2037
- Phase
- Interventional
- 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
Who may be able to join
- Age> at 18 years old,
- Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,
- Patient in ICM at diagnosis
- a digestive cancer (esophagus, stomach, pancreas, colon, rectum, anal canal) or
- gynecological cancer (ovary, endometrium, cervix) or
- breast cancer or
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- sarcoma.
- Naïve patient of any treatment for the present cancer,
- Patient requiring treatment involving at least one (or more) tumor surgery (s)
- Patient who has accepted supplementary blood samples,
- Patient having given his informed, written and express consent.
Who cannot join
- Patient not affiliated to a social protection scheme,
- Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,
- Pregnant and / or nursing women,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut regional du Cancer - Val d Aurelle
Montpellier, 34298
BLEUSE Jean-pierre, MHD
AZRIA David, PhD
About this study
Official title: Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.
Read the detailed description
Implementation of a translational research project is part of the Cancer Plan 2014-2019 and its axis 5 "Advancing clinical and translational research in oncology", and more precisely Action 5.1.
The national health strategy launched by the Minister of Health and the Minister of Research will allow a better integration between research, innovation, medicine and care for the benefit of patients and society.
Moreover, knowledge of mechanisms involved in the phenomena of tumor invasion, metastatic dissemination, resistance to treatment and companion testing is crucial for the emergence of new biomarkers and therapeutic innovation.
However, the study of the earliest phases of tumorigenesis as well as of the advanced stages of the disease are currently limited by the low availability of blood and tissue samples combined with quality and reliable clinical data.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients.
Integrated research associated with quality biological research is the guarantee of medical progress.
The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects
- Conditions
- Digestive Cancer, Gynecologic Cancer, Breast Cancer, Sarcoma
- Being tested
- biological collection
- Medical subject headings
- Gastrointestinal Neoplasms, Breast Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological collectionBiological
- Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery.
- Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| Biological collection | Experimental | samples of different natures:
* Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery.
* Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out.
In parallel to this biological collection, standardized clinical data will be entered into a database Receives: Biological: biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who consent to participate in the study
the proportion of patients who consent to participate in the study among the screened patients
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start27 Jul 2017
- Primary completionNov 2027 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean pierre Bleuse, Study chair, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449264
- Sponsor's protocol ID
- ICM-URC2017/37
- Acronym
- BCBInstitut
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2017
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
- ClinicalTrials.gov ID
- NCT03449264
- Acronym / sponsor ID
- BCBInstitut / ICM-URC2017/37
- Conditions
- Digestive Cancer, Gynecologic Cancer, Breast Cancer, Sarcoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects.
Detailed description
Implementation of a translational research project is part of the Cancer Plan 2014-2019 and its axis 5 "Advancing clinical and translational research in oncology", and more precisely Action 5.1.
The national health strategy launched by the Minister of Health and the Minister of Research will allow a better integration between research, innovation, medicine and care for the benefit of patients and society.
Moreover, knowledge of mechanisms involved in the phenomena of tumor invasion, metastatic dissemination, resistance to treatment and companion testing is crucial for the emergence of new biomarkers and therapeutic innovation.
However, the study of the earliest phases of tumorigenesis as well as of the advanced stages of the disease are currently limited by the low availability of blood and tissue samples combined with quality and reliable clinical data.
To meet these demands, the research must then integrate databases creation open to researchers and the ongoing evaluation of the impact of projects on the health of cancer patients.
Integrated research associated with quality biological research is the guarantee of medical progress.
The multidisciplinary structure around collections of biological resources will enable the various actors to harmonize not only the collection but also the sharing of their data with a view to making them available for medico-scientific projects at a regional and national dimension. The Clinical Biological Database (BCB) should be used to identify and characterize new molecular markers for better diagnosis and / or treatment. It should also permit to optimize the collection of all this information, their integration and their transversal exploitation by different research disciplines (epidemiological, fundamental, translational, clinical).
The BCB is a tool:
- for research in analytical and public health epidemiology, biological research and for the development of data useful for clinical research and therapeutic trials;
- to help scientists understand and explain phenomena ranging from the interaction of molecules to the whole metabolism of the organism in normal and pathological situations;
- to identify potential strategies for prevention, diagnosis, management and analysis of cancer subtypes.
The creation of a broad clinical and biological prospective base dedicated to different types of cancer is essential for the development of such projects
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological collection | Experimental | Biological: biological collectionsamples of different natures: * Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. * Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out. In parallel to this biological collection, standardized clinical data will be entered into a database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age> at 18 years old,
- Patient with invasive or in situ tumor pathology (proven or suspected) any stage confounded,
- Patient in ICM at diagnosis
- Naïve patient of any treatment for the present cancer,
- Patient requiring treatment involving at least one (or more) tumor surgery (s)
Key exclusion criteria (5 listed)
- Patient not affiliated to a social protection scheme,
- Patient whose regular follow-up is a priori impossible for psychological, familial, social or geographical reasons,
- Pregnant and / or nursing women,
- Subject under tutelage, curatorship or safeguard of justice,
- Patient in an emergency situation.
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 |
|---|---|---|
| biological collection* Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. * Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out. | Biological | Biological collection |
Primary outcome
Proportion of patients who consent to participate in the study
Time frame: through study completion, an average of 1 year
the proportion of patients who consent to participate in the study among the screened patients
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 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
jean pierre Bleuse study chair
Institut régional du Cancer de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological collection in people with Digestive Cancer and Gynecologic Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact david azria (+33467613102, david.azria@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who consent to participate in the study (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.