NCT05422547

Role of Immunoscore® in Stage II-III Colorectal Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: D'Or Institute for Research and Education · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The proposed study is a bidirectional analytical study, composed of a retrospective and a prospective cohorts. Patients with stage II - III colorectal cancer undergoing oncological surgery will be analyzed. The study will include a convenience sample of 100 individuals. Fifty cases will be included retrospectively and fifty prospectively. The study aims to evaluate the benefit of using the Immunoscore test as a predictor of recurrence in patients with operated stage II-III colon tumors. It will also be evaluated the impact on oncologic decision and costs.

Conditions

• Colon Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immunoscore Colon Test	Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of localized colon cancer. The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-12-30
• Completion: 2023-12-30
• First posted: 2022-06-16
• Last updated: 2022-06-16

Locations

2 sites across 1 country: Brazil