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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sampling
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with metastatic colorectal cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2018
Last Updated
July 27, 2018
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03613194
Brief Title
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
Acronym
DISCOVER
Official Title
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with metastatic colorectal cancer
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identification and characterization of the tumoral intermediaries on the overflowing peritoneal
Description
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.
Time Frame
Up to 24 months
Title
Identification and characterization of the tumoral intermediaries on the portal blood
Description
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.
Time Frame
Up to 24 months
Title
Identification and characterization of the tumoral intermediaries on the peripheral blood
Description
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.
Time Frame
Up to 24 months
Title
Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)
Description
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.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane GOERE, MD
Phone
0142114211
Ext
+33
Email
diane.goere@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny JAULIN, MD
Phone
0142114211
Ext
+33
Email
fanny.jaulin@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane GOERE, MD
Phone
0142114211
Ext
+33
Email
diane.goere@gustaveroussy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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