Role of Immunoscore® in Stage II-III Colorectal Cancer

Colon Adenocarcinoma Clinical Trial

Official title:

Role of Immunoscore® in Stage II-III Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422547
• Other study ID #: Immunoscore®
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2022
• Source: D'Or Institute for Research and Education
• Contact: Camila M Moniz, PhD
• Phone: 55 11 2109-8855
• Email: camila.venchiarutti[@]idor.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Adenocarcinoma
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto D'Or de Pesquisa e Ensino - Brasília	Brasília	Distrito Federal
Brazil	Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro	Rio De Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Diagnosticos da America SA, HalioDx

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour recurrence	Impact of Immunoscore stratification on tumor recurrence at 2 years	2 years
Secondary	Disease-free survival (DFS)	Impact of Immunoscore stratification on DFS at 5 years	5 years
Secondary	Overall survival (OS)	Impact of Immunoscore stratification on OS at 5 years	5 years
Secondary	DFS acoording tumor side	Impact of Immunoscore stratification on DFS in right and left tumors at 3 years	3 years
Secondary	OS acoording tumor side	Impact of Immunoscore stratification on OS in right and left tumors at 3 years	3 years
Secondary	Indication of adjuvant therapy	Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions	6 months
Secondary	Biomarker measurements	Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status	6 months
Secondary	Possible economic impact	Difference in monetary value due to Immuno Score stratification and chemotherapy indication	5 years