Clinical trial · Observational
Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunoscore test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3 months treatment
- description
- FOLFOX or CAPOX
- interventionNames
- Diagnostic Test: Immunoscore test
- label
- 6 months treatment
- description
- FOLFOX or CAPOX
- interventionNames
- Diagnostic Test: Immunoscore test
Primary outcomes (1)
- measure
- disease-free survival (DFS)
- timeFrame
- 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPages F, Andre T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol. 2020 Jul;31(7):921-929. doi: 10.1016/j.annonc.2020.03.310. Epub 2020 Apr 12. PMID 32294529