Role of Immunoscore® in Stage II-III Colorectal Cancer

Sponsor

D'Or Institute for Research and Education (Other)

Overall Status

Recruiting

CT.gov ID

NCT05422547

Collaborator

HalioDx (Industry), Diagnosticos da America SA (Other)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colon Adenocarcinoma	Diagnostic Test: Immunoscore Colon Test

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Role of Immunoscore® in Stage II-III Colorectal Cancer

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

Tumour recurrence [2 years]
Impact of Immunoscore stratification on tumor recurrence at 2 years

Secondary Outcome Measures

Disease-free survival (DFS) [5 years]
Impact of Immunoscore stratification on DFS at 5 years
Overall survival (OS) [5 years]
Impact of Immunoscore stratification on OS at 5 years
DFS acoording tumor side [3 years]
Impact of Immunoscore stratification on DFS in right and left tumors at 3 years
OS acoording tumor side [3 years]
Impact of Immunoscore stratification on OS in right and left tumors at 3 years
Indication of adjuvant therapy [6 months]
Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions
Biomarker measurements [6 months]
Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status
Possible economic impact [5 years]
Difference in monetary value due to Immuno Score stratification and chemotherapy indication

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto D'Or de Pesquisa e Ensino - Brasília	Brasília	Distrito Federal	Brazil
2	Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro	Rio De Janeiro		Brazil