CClinicalTrials.gg
Status unknownNCT03613194DISCOVERUpdated Aug 3, 2018

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

An interventional study of Sampling in Colorectal Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 50 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureSampling

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 24 months

  2. 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.

    Time frame: Up to 24 months

  3. 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.

    Time frame: Up to 24 months

  4. 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.

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03613194
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Jun 25, 2018
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Aug 3, 2018

Study contacts

Diane GOERE, MD
Contact
diane.goere@gustaveroussy.fr
0142114211 ext. +33
Fanny JAULIN, MD
Contact
fanny.jaulin@gustaveroussy.fr
0142114211 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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