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

NCT03613194 | Unknown

• 2 other identifiers: 2017-A02878-452017/2511
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Patients with metastatic colorectal cancer

OTHER

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.

Procedure: Sampling

Interventions

Sampling PROCEDURE

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.

Patients with metastatic colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None metastatic colorectal cancer
• Cancer of appendicular origin
• Patients deprived of liberty or unable to give his assent

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val De Marne, 94805, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Diane GOERE, MD

CONTACT

0142114211; diane.goere@gustaveroussy.fr

Fanny JAULIN, MD

CONTACT

0142114211; fanny.jaulin@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: June 25, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)