| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-MSI-STATUS | MSI-H | IA |
Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap. | MSI-H (microsatellite instability-high) CRC is the primary biomarker for first-line pembrolizumab monotherapy (KEYNOTE-177; mPFS 16.5 vs 8.2 mo, HR 0.60; FDA-approved 2020 for 1L mCRC MSI-H). Pembrolizumab is also FDA-approved tumor-agnostically for MSI-H/dMMR solid tumors (KEYNOTE-158, 2017). MSS/pMMR CRC does not benefit from ICI monotherapy. MSI-H (~5% of metastatic CRC) is typically detected by PCR-based fragment analysis or NGS; result correlates closely with IHC-based dMMR testing (MLH1/MSH2/MSH6/PMS2 loss). Threshold selection (MSI-H positive/negative) enforced by algorithm layer; this BMA entry surfaces ESCAT tier context only. For Lynch syndrome germline implications see BMA entries for BIO-MLH1 / BIO-MSH2 / BIO-MSH6 / BIO-PMS2. | pembrolizumab monotherapy (MSI-H 1L mCRC per SRC-KEYNOTE-177-ANDRE-2020, SRC-NCCN-COLON-2025) pembrolizumab monotherapy (tumor-agnostic MSI-H per SRC-ESMO-CRC-2024) |
|
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | radiologist | Specialist review | Imaging findings present — radiologist needed for staging/restaging. |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT07112690 | Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment | NA | RECRUITING | Emory University | — | Small N (<50) Single country | |
| NCT05929820 | Impact of Protect Your Colon™ on CRC Screening | NA | RECRUITING | Cedars-Sinai Medical Center | — | Single country | |
| NCT07417488 | GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas | PHASE1 | RECRUITING | Thomas Jefferson University | — | Phase 1 only Small N (<50) Single country | |
| NCT06649123 | Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer | N/A | RECRUITING | Origin Sciences | — | Single country | |
| NCT06307249 | Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA | PHASE1 | RECRUITING | Lebanese University | — | Phase 1 only Single country | |
| NCT06562543 | A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer | PHASE4 | RECRUITING | Takeda | — | — | |
| NCT07432633 | [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications | PHASE1 / PHASE2 | RECRUITING | Blue Earth Diagnostics | — | Single country | |
| NCT02838836 | Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers | N/A | RECRUITING | University of Missouri-Columbia | — | Surrogate endpoint only Single country | |
| NCT07150247 | Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer | PHASE2 | RECRUITING | Sun Yat-sen University | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT05850130 | Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients | NA | RECRUITING | GERCOR - Multidisciplinary Oncology Cooperative Group | — | Single country |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Standard plan FOLFOX (mFOLFOX6) (REG-FOLFOX) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan CAPOX (XELOX) (REG-CAPOX) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT07112690 Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05929820 Impact of Protect Your Colon™ on CRC Screening No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07417488 GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarcinomas No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06649123 Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06307249 Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06562543 A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07432633 [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT02838836 Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07150247 Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05850130 Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-06-27.