Development of Clinical and Biological Database
BCBInstitut
Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
1 other identifier
interventional
4,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 27, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2037
February 12, 2025
February 1, 2025
10.3 years
August 29, 2017
February 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
through study completion, an average of 1 year
Other Outcomes (1)
Quality of life assessment at baseline for all participants in the study
through study completion, an average of 1 year
Study Arms (1)
Biological collection
EXPERIMENTALsamples 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
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut regional du Cancer - Val d Aurelle
Montpellier, 34298, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
jean pierre Bleuse
Institut régional du Cancer de Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2017
First Posted
February 28, 2018
Study Start
July 27, 2017
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2037
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share