| 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) |
|
| 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) |
|---|---|---|---|---|---|---|---|
| NCT05970133 | Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer | NA | RECRUITING | National Taiwan University Hospital | — | Single country | |
| NCT05967143 | Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry) | N/A | RECRUITING | Sirtex Medical | — | — | |
| NCT07312786 | Testing the Feasibility of a Virtual Application to Support Breast and Colorectal Cancer Survivors | NA | RECRUITING | Nova Scotia Health Authority | — | Single country | |
| NCT05994482 | Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study | N/A | RECRUITING | VA Office of Research and Development | — | Single country | |
| NCT06542835 | Community Partnership for Telehealth Solutions to Convey Information and Enhance Care | NA | RECRUITING | University of Arizona | — | Single country | |
| NCT04190589 | Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer | NA | RECRUITING | Vejle Hospital | — | Small N (<50) Single country | |
| NCT07035691 | New bioMarkers tO straTIfy cOlorectal caNcer Referrals | N/A | RECRUITING | Queen Mary University of London | — | Single country | |
| NCT05691491 | Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness | PHASE1 / PHASE2 | RECRUITING | National Cancer Institute (NCI) | — | Single country | |
| NCT02185443 | Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases | PHASE2 | RECRUITING | University of Sao Paulo | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT06765252 | Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients | N/A | RECRUITING | Ain Shams University | — | 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 · NCT05970133 Robotic Versus Laparoscopy NOSE for Stage I-III Left-sided Colon Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05967143 Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07312786 Testing the Feasibility of a Virtual Application to Support Breast and Colorectal Cancer Survivors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05994482 Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06542835 Community Partnership for Telehealth Solutions to Convey Information and Enhance Care No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04190589 Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07035691 New bioMarkers tO straTIfy cOlorectal caNcer Referrals No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05691491 Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT02185443 Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06765252 Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian 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: 2026-06-11.