Role of Immunoscore® in Stage II-III Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colon Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Anatomopathological diagnosis of colorectal adenocarcinoma
2. Stage II - III (AJCC 8th edition)
3. Patient undergoing surgery with curative intent

Exclusion Criteria

1. Current or previous diagnosis (within the last 5 years) of another invasive primary malignant neoplasm, with the exception of non-melanoma skin neoplasm
2. Presence of distant metastatic disease evidenced in imaging tests

Eligible Sex

ALL

Accepts Healthy Volunteers

No