Clinical and Biological Database in Colon Cancer and Colic Tumors

Cancer Colon Clinical Trial

— BCBCOLON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976960
• Other study ID #: BCB2014/01
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: December 2030

Study information

• Verified date: August 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Jean-Pierre BLEUSE, M.D
• Phone: 4 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Colon
• Colic
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Montpellier	Montpellier	Hérault
France	Institut Régional du cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of clinical risk factors for colorectal cancer		Until the study completion : 6 years
Primary	Number of biological risk factors for colorectal cancer		Until the study completion : 6 years

External Links

•   National estimate of cancer incidence and mortality in France between 1980 and 2012.