Role of Immunoscore® in Stage II-III Colorectal Cancer
1 other identifier
observational
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJune 16, 2022
June 1, 2022
9 months
May 30, 2022
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumour recurrence
Impact of Immunoscore stratification on tumor recurrence at 2 years
2 years
Secondary Outcomes (7)
Disease-free survival (DFS)
5 years
Overall survival (OS)
5 years
DFS acoording tumor side
3 years
OS acoording tumor side
3 years
Indication of adjuvant therapy
6 months
- +2 more secondary outcomes
Interventions
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 Criteria
Patients with stage II - III colorectal cancer undergoing oncological surgery.
You may qualify if:
- Anatomopathological diagnosis of colorectal adenocarcinoma
- Stage II - III (AJCC 8th edition)
- Patient undergoing surgery with curative intent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D'Or Institute for Research and Educationlead
- HalioDxcollaborator
- Diagnosticos da America SAcollaborator
Study Sites (2)
Instituto D'Or de Pesquisa e Ensino - Brasília
Brasília, Federal District, Brazil
Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
Rio de Janeiro, Brazil
Biospecimen
Colorectal cancer resection surgical biospecimen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paulo M Hoff, PhD
Instituto D'Or de Pesquisa e Ensino
- STUDY CHAIR
Fernando A Soares, PhD
Instituto D'Or de Pesquisa e Ensino
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2022
First Posted
June 16, 2022
Study Start
April 1, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2023
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share