NCT03946033

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted. The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM. With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III). Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.

Conditions

• Colonic Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immunoscore Colon Test	Immunoscore Colon is a CE-marked in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer. The test uses immunohistochemistry, digital pathology techniques and a dedicated software.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-12-01
• Completion: 2021-02-01
• First posted: 2019-05-10
• Last updated: 2019-08-30

Locations

21 sites across 1 country: France