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| Name | Class |
|---|---|
| HalioDx | INDUSTRY |
| Diagnosticos da America SA | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoscore Colon Test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour recurrence | Impact of Immunoscore stratification on tumor recurrence at 2 years | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | Impact of Immunoscore stratification on DFS at 5 years | 5 years |
| Overall survival (OS) | Impact of Immunoscore stratification on OS at 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage II - III colorectal cancer undergoing oncological surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camila M Moniz, PhD | Contact | 55 11 2109-8855 | camila.venchiarutti@idor.org | |
| Ingrid P Barbosa | Contact | 55 11 2109-8855 | ingrid.rbarbosa@idor.org |
| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto D'Or de Pesquisa e Ensino - BrasÃlia | Recruiting | BrasÃlia | Federal District | Brazil |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Colorectal cancer resection surgical biospecimen
| 5 years |
| DFS acoording tumor side | Impact of Immunoscore stratification on DFS in right and left tumors at 3 years | 3 years |
| OS acoording tumor side | Impact of Immunoscore stratification on OS in right and left tumors at 3 years | 3 years |
| Indication of adjuvant therapy | Percentage of patients who had an indication for adjuvant therapy through the evaluation of medical prescriptions | 6 months |
| Biomarker measurements | Correlation of Immunoscore stratification with the KRAS, NRAS and BRAF status | 6 months |
| Possible economic impact | Difference in monetary value due to Immuno Score stratification and chemotherapy indication | 5 years |
| Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro | Recruiting | Rio de Janeiro | Brazil |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |