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

July 27, 2018 updated by: Gustave Roussy, Cancer Campus, Grand Paris
To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val De Marne
      • Villejuif, Val De Marne, France, 94805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with metastatic colorectal cancer

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A02878-45
  • 2017/2511 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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