Colon Adenocarcinoma
Conditions
Keywords
colorectal cancer, colon carcinoma, immunoscore, immune response, predictive markers, prognostic markers, tumour microenvironment
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.
Interventions
DIAGNOSTIC_TESTImmunoscore 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
HalioDx
Diagnosticos da America SA
D'Or Institute for Research and Education
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumour recurrence | 2 years | Impact of Immunoscore stratification on tumor recurrence at 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Disease-free survival (DFS) | 5 years | Impact of Immunoscore stratification on DFS at 5 years |
| 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 |
| Indication of adjuvant therapy | 6 months | Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions |
Countries
Brazil
Contacts
Primary ContactCamila M Moniz, PhD
Backup ContactIngrid P Barbosa
Outcome results
None listed