Clinical and Biological Database in Colon Cancer and Colic Tumors (BCBCOLON)

November 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors

Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.

Study Type

Interventional

Enrollment (Anticipated)

600

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 Régional Du Cancer de Montpellier
        • Contact:
          • Eric ASSENAT, MD
    • Hérault
      • Montpellier, Hérault, France, 34298

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
  2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
  3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
  4. Patient with familial polyposis eligible for colectomy
  5. Age > 18 years
  6. Signed informed consent

Exclusion Criteria:

  1. Patient not affiliated to Social Protection system
  2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
  3. Patient under guardianship
  4. Minor patient

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

For all the patients include in the study :

samples of blood samples collected before or after surgery but also samples in paraffin-embedded tissue sections.

In parallel to this biological collection, standardized clinical data will be entered into a database
Other: Biological collection
The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of clinical risk factors for colorectal cancer
Time Frame: Until the study completion : 6 years
Until the study completion : 6 years
Number of biological risk factors for colorectal cancer
Time Frame: Until the study completion : 6 years
Until the study completion : 6 years

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: ERIC ASSENAT, M.D, Institut Régional Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 19, 2018

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB2014/01

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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