Development of Clinical and Biological Database (BCBInstitut)
Primary Purpose
Digestive Cancer, Gynecologic Cancer, Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological collection
Sponsored by
About this trial
This is an interventional other trial for Digestive Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Institut regional du Cancer - Val d AurelleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological collection
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03449264
First Posted
August 29, 2017
Last Updated
November 3, 2021
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT03449264
Brief Title
Development of Clinical and Biological Database
Acronym
BCBInstitut
Official Title
Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Cancer, Gynecologic Cancer, Breast Cancer, Sarcoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2850 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological collection
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
biological collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients who consent to participate in the study
Description
the proportion of patients who consent to participate in the study among the screened patients
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Quality of life assessment at baseline for all participants in the study
Description
Questionnaire assessment to measure the quality of life at baseline
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
david azria
Phone
+33467613102
Email
david.azria@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean pierre Bleuse
Organizational Affiliation
Institut régional du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut regional du Cancer - Val d Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BLEUSE Jean-pierre, MHD
First Name & Middle Initial & Last Name & Degree
AZRIA David, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of Clinical and Biological Database
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