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

Primary Purpose

Cancer Colon

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer Colon focused on measuring cancer, colon, tumor, colic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de MontpellierRecruiting
  • Institut Régional du cancer de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological collection

Arm Description

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

Outcomes

Primary Outcome Measures

Number of clinical risk factors for colorectal cancer
Number of biological risk factors for colorectal cancer

Secondary Outcome Measures

Full Information

First Posted
June 5, 2019
Last Updated
November 3, 2021
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT03976960
Brief Title
Clinical and Biological Database in Colon Cancer and Colic Tumors
Acronym
BCBCOLON
Official Title
Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2030 (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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Colon
Keywords
cancer, colon, tumor, colic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological collection
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Biological collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of clinical risk factors for colorectal cancer
Time Frame
Until the study completion : 6 years
Title
Number of biological risk factors for colorectal cancer
Time Frame
Until the study completion : 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient undergoing colon cancer surgery (stage I, II, III and IV) Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp), Patient with familial polyposis eligible for colectomy Age > 18 years Signed informed consent Exclusion Criteria: Patient not affiliated to Social Protection system Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons Patient under guardianship Minor patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre BLEUSE, M.D
Phone
4 67 61 31 02
Ext
+ 33
Email
DRCI-icm105@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ERIC ASSENAT, M.D
Organizational Affiliation
Institut régional du cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
CHRU de Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Assénat, MD
Phone
467330137
Ext
+33
Email
e-assenat@chu-montpellier.fr
Facility Name
Institut Régional du cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ERIC ASSENAT, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.google.com/search?client=firefox-b-d&sxsrf=ALeKk0251JuQRT2bZiWL8ut7KwGhX0TKeQ:1596454499279&q=Estimation+nationale+de+l%27incidence+et+de+la+mortalit%C3%A9+par+cancer+en+France+entre+1980+et+2012.+Partie+1-+Tumeurs+solides.+Traitement+:+INCA+2013.&spell=1&sa=X&ved=2ahUKEwj7lNG6-P7qAhVKxIUKHZeSCMMQBSgAegQICxAq&biw=1920&bih=1006
Description
National estimate of cancer incidence and mortality in France between 1980 and 2012.

Learn more about this trial

Clinical and Biological Database in Colon Cancer and Colic Tumors

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