Development of Clinical and Biological Database (BCBInstitut)

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34298
        • Recruiting
        • Institut regional du Cancer - Val d Aurelle
        • Contact:
          • BLEUSE Jean-pierre, MHD
        • Principal Investigator:
          • AZRIA David, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological collection

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
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment at baseline for all participants in the study
Time Frame: through study completion, an average of 1 year
Questionnaire assessment to measure the quality of life at baseline
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: jean pierre Bleuse, Institut régional du Cancer de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2017

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2037

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM-URC2017/37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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