Role of Immunoscore® in Stage II-III Colorectal Cancer

D'Or Institute for Research and Education100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Colon Adenocarcinoma

Interventions

Immunoscore Colon TestDIAGNOSTIC_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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Instituto D'Or de Pesquisa e Ensino - Brasília

Brasília, Federal District, Brazil

RECRUITING

Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro

Rio de Janeiro, Brazil

RECRUITING

Outcomes

Primary Outcomes

Tumour recurrence

Impact of Immunoscore stratification on tumor recurrence at 2 years

Time frame: 2 years

Secondary Outcomes

Disease-free survival (DFS)

Impact of Immunoscore stratification on DFS at 5 years

Time frame: 5 years

Overall survival (OS)

Impact of Immunoscore stratification on OS at 5 years

Time frame: 5 years

DFS acoording tumor side

Impact of Immunoscore stratification on DFS in right and left tumors at 3 years

Time frame: 3 years

OS acoording tumor side

Impact of Immunoscore stratification on OS in right and left tumors at 3 years

Time frame: 3 years

Indication of adjuvant therapy

Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions

Time frame: 6 months

Biomarker measurements

Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status

Time frame: 6 months

Possible economic impact

Difference in monetary value due to Immuno Score stratification and chemotherapy indication

Time frame: 5 years

Central Contacts

Camila M Moniz, PhD

CONTACT

55 11 2109-8855 camila.venchiarutti@idor.org

Ingrid P Barbosa

CONTACT

55 11 2109-8855 ingrid.rbarbosa@idor.org

Data from ClinicalTrials.gov

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