Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer

Colorectal Cancer Clinical Trial

— DISCOVER  

Official title:

Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613194
• Other study ID #: 2017-A02878-45
• Secondary ID: 2017/2511
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Diane GOERE, MD
• Phone: 0142114211
• Email: diane.goere[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Histological Diagnosis of stage IV colorectal cancer

• Hepatic metastasis and/or peritoneal potentially resecable

• Patient affiliated with a mode of the social security or recipient of such a mode

• Information of the patient or his legal representative and collection of his assent

Exclusion Criteria:

• None metastatic colorectal cancer

• Cancer of appendicular origin

• Patients deprived of liberty or unable to give his assent

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Sampling
After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples. The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern: Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal Peritoneal liquid none tumoral peritoneum Portal blood Peripheral blood Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum. In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator.

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and characterization of the tumoral intermediaries on the overflowing peritoneal	After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.	Up to 24 months
Primary	Identification and characterization of the tumoral intermediaries on the portal blood	After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.	Up to 24 months
Primary	Identification and characterization of the tumoral intermediaries on the peripheral blood	After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.	Up to 24 months
Primary	Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)	After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.	Up to 24 months