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RecruitingNCT03449264BCBInstitutUpdated Feb 12, 2025

Development of Clinical and Biological Database

An interventional study of biological collection in Digestive Cancer, Gynecologic Cancer and Breast Cancer, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
4,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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

02

Conditions studied

  • Digestive Cancer
  • Gynecologic Cancer
  • Breast Cancer
  • Sarcoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4,000 participants (estimated)

Study arms

  • 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

Interventions

  • Biologicalbiological 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.

05

What researchers measure

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

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. Quality of life assessment at baseline for all participants in the study

    Questionnaire assessment to measure the quality of life at baseline

    Time frame: through study completion, an average of 1 year

06

Study locations

1 of 1 sites recruiting
  • Institut regional du Cancer - Val d Aurelle
    Montpellier, 34298, France
    • BLEUSE Jean-pierre, MHD · Contact
    • AZRIA David, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449264
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jul 27, 2017
Primary completion
Nov 2027 (estimated)
Completion
Nov 2037 (estimated)
Last update
Feb 12, 2025

Study contacts

david azria
Contact
david.azria@icm.unicancer.fr
+33467613102
jean pierre Bleuse
study chair · Institut régional du Cancer de Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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