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Clinical Trials/NCT03613194
NCT03613194UnknownNot Applicable

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

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country50 target enrollmentStarted: June 25, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Identification and characterization of the tumoral intermediaries on the overflowing peritoneal

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Sampling (Procedure)

Outcomes

Primary Outcomes

Identification and characterization of the tumoral intermediaries on the overflowing peritoneal

Time Frame: Up to 24 months

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.

Identification and characterization of the tumoral intermediaries on the portal blood

Time Frame: Up to 24 months

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.

Identification and characterization of the tumoral intermediaries on the peripheral blood

Time Frame: Up to 24 months

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.

Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)

Time Frame: Up to 24 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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