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Role of Immunoscore® in Stage II-III Colorectal Cancer

NCT05422547 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-06-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • HalioDx

    collaborator INDUSTRY

  • Diagnosticos da America SA

    collaborator UNKNOWN

  • D'Or Institute for Research and Education

    lead OTHER

Principal Investigators

  • Paulo M Hoff, PhD · Instituto D'Or de Pesquisa e Ensino

  • Fernando A Soares, PhD · Instituto D'Or de Pesquisa e Ensino

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-30
Completion
2023-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422547 on ClinicalTrials.gov