Clinical trial · Interventional
Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer
A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery
NCT03946033CI-TRIAL-00040331PROSCOREwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Canceled by Immunoscore's manufacturer
Summary
Brief summary (as posted)
Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunoscore Colon Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- All participants are included in the same arm. Immunoscore Colon Test is applied on a tumor sample and the result is kept secret. In the Multidisciplinary Meeting evaluating the adjuvant therapy of the participant, a first therapeutic decision is taken, then Immunoscore result will be disclosed and the Multidisciplinary Meeting will take a second decision.
- interventionNames
- Diagnostic Test: Immunoscore Colon Test
Primary outcomes (1)
- measure
- Modification rate of adjuvant therapeutic strategy
- timeFrame
- At the multidisciplinary meeting, up to 6 weeks after the cancer surgery
- description
- Modifications of adjuvant therapy, type and/or duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically/histologically proven colon adenocarcinoma * non-metastatic cancer * Stage II or III adenocarcinoma * Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting * No macroscopic or microscopic proof of residual disease during surgery (R0 margins) * Available surgical material: FFPE tumor samples * Post-operative adjuvant chemotherapy considered during multidisciplinary meeting * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Patient having signed a written informed consent prior to any trial specific procedures * Patient affiliated to the social security system or equivalent Exclusion Criteria: * Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma * Patients for which adjuvant chemotherapy is contra-indicated * Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy) * Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision * Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct * Person deprived of liberty or under the authority of a legal guardian * Person unable to understand the study or to comply with the protocol procedures
References
Publications (1)
- BACKGROUNDPages F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Musina AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10. PMID 29754777