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Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03422601
Recruitment Status : Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
HalioDx
Methodology and quality of life unit in oncology, University hospital of Besancon
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary:

The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy.

Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment).

Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.


Condition or disease Intervention/treatment
Colorectal Cancer Stage III Colon Cancer Diagnostic Test: Immunoscore test

Detailed Description:
Adult patients of both genders who have underwent surgical resection of stage III colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified FOLFOX 6 or CAPOX in the IDEA France trial.

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Study Type : Observational
Actual Enrollment : 1122 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment: an Ancillary Study of IDEA France Study
Actual Study Start Date : July 13, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Group/Cohort Intervention/treatment
3 months treatment
FOLFOX or CAPOX
Diagnostic Test: Immunoscore test
To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

6 months treatment
FOLFOX or CAPOX
Diagnostic Test: Immunoscore test
To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.




Primary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: 3 years ]
    DFS is defined as the time from randomization to relapse or death, whichever occurred first. Secondary colon cancers are regarded as DFS events, whereas non-colon tumors are to be disregarded in the analysis. Patients with no defined events observed during the follow-up will be censored at the date of last disease evaluation which showed no evidence of relapse, or secondary primary colon cancer.


Biospecimen Retention:   Samples With DNA
Tissues: colon carcinoma and adjacent non-tumor tissues collected in formalin fixed paraffin embedded blocks.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patient of both genders who have underwent surgical resection of stage III colon carcinoma
Criteria

Inclusion Criteria:

  • Patient and tumor characteristics; 3-year clinical Follow-Up
  • Data regarding other markers (eg. MSI)
  • FFPE blocks available, including core tumor + invasive margin regions

Exclusion Criteria:

• Bouin fixative

Sample type:

• adjacent FFPE slices (4 μm each) per case (although only one slide is required for CD3 and one for CD8, with center of tumor (CT) and the invasive margin(IM) cut from FFPE blocks no more than 4 months before the Immunoscore® testing


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422601


Locations
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France
Hôpital Saint Antoine
Paris, France
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
HalioDx
Methodology and quality of life unit in oncology, University hospital of Besancon
Investigators
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Study Director: Thierry ANDRE, MD Hôpital Saint Antoine

Additional Information:
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Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT03422601     History of Changes
Other Study ID Numbers: IDEA ancillary study
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents