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In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.
The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gene panel | Diagnostic Test | comprehensive cancer gene panel targeting regions in 37 clinically relevant cancer genes in FFPE tumor tissue blocks |
| Measure | Description | Time Frame |
|---|---|---|
| association between gene mutational status and overall survival | the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up | 24 months |
| association between gene mutational status and disease-free survival | the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptives | Association of any gene mutation tumor pathological stages. | 24 months |
| Descriptives | Association of any gene mutation tumor budding. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent surgical resection of early-stage (II-III) colorectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Papaxoinis | Contact | +302106409000 | georgexoinis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| George Fountzilas, Prof | Hellenic Cooperative Oncology Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Cooperative Oncology Group | Recruiting | Athens | 11526 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31631858 | Background | Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0. | |
| 31602389 | Background | Seufferlein T, Simoes C, Kude F, Ettrich TJ. Molecular Approaches to Metastatic Colorectal Cancer: Better Diagnosis - Better Treatment? Visc Med. 2019 Aug;35(4):259-264. doi: 10.1159/000500617. Epub 2019 Jul 11. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks
| 24 months |
| Descriptives | Association of any gene mutation with microstatellite instability. | 24 months |
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| 31786718 | Background | Cohen R, Rousseau B, Vidal J, Colle R, Diaz LA Jr, Andre T. Immune Checkpoint Inhibition in Colorectal Cancer: Microsatellite Instability and Beyond. Target Oncol. 2020 Feb;15(1):11-24. doi: 10.1007/s11523-019-00690-0. |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |