Role of Immunoscore® in Stage II-III Colorectal Cancer

June 14, 2022 updated by: D'Or Institute for Research and Education

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
        • Contact:
          • Ingrid P Barbosa
          • Phone Number: 55 11 2109-8855
        • Principal Investigator:
          • Mariana B Siqueira, MD
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino - Brasília
        • Contact:
          • Ingrid P Barbosa
          • Phone Number: 55 11 2109-8855
        • Principal Investigator:
          • Lucila S Rocha, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stage II - III colorectal cancer undergoing oncological surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour recurrence
Time Frame: 2 years
Impact of Immunoscore stratification on tumor recurrence at 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D'Or Institute for Research and Education

Collaborators

HalioDx
Diagnosticos da America SA

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2022

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (ACTUAL)

June 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Immunoscore®

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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