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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2019-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Stage III Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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3 months treatment

FOLFOX or CAPOX

Immunoscore test

Intervention Type DIAGNOSTIC_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

Immunoscore test

Intervention Type DIAGNOSTIC_TEST

To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

Interventions

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Immunoscore test

To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No