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Development of Clinical and Biological Database (BCBInstitut)

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ClinicalTrials.gov Identifier: NCT03449264
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

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.


Condition or disease Intervention/treatment Phase
Digestive Cancer Gynecologic Cancer Breast Cancer Sarcoma Biological: biological collection Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2850 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Monocentric and Prospective Clinical and Biological Database in Digestive Cancers, Gynecological Cancers, Breast Cancers and Sarcomas
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> at 18 years old,
  • Patient with invasive 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449264


Contacts
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Contact: david azria +33467613102 david.azria@icm.unicancer.fr

Locations
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France
Institut regional du Cancer - Val d Aurelle Recruiting
Montpellier, France, 34298
Contact: BLEUSE Jean-pierre, MHD         
Principal Investigator: AZRIA David, PhD         
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: jean pierre Bleuse Institut régional du Cancer de Montpellier

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT03449264     History of Changes
Other Study ID Numbers: ICM-URC2017/37
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Sarcoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type