Post-treatment ctDNA-detected molecular residual disease (MRD) — any positive call by a t...

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ID	`RF-PAN-CTDNA-MRD-POSITIVE`
Тип	Тривожна ознака
Статус	переглянуто 2026-04-29 \| очікує клінічного підпису
Хвороби	Не вказано
Джерела	`SRC-CIVIC` `SRC-ESMO-CRC-2024` `SRC-NCCN-COLON-2025`

Походження тривожної ознаки

Визначення	Post-treatment ctDNA-detected molecular residual disease (MRD) — any positive call by a tumor-informed (Signatera, RaDaR) or tumor-agnostic liquid-biopsy assay after curative-intent surgery / chemoradiation, in the absence of imaging-detectable disease. Tumor-type-agnostic concept; best validated in resected stage II-III colon cancer (GALAXY / CIRCULATE-Japan, Kotani Nat Med 2023; ALTAIR planned readout) — ctDNA- positive at week 4 post-op carries 6-12× higher 24-month recurrence hazard vs ctDNA-negative, identifying the subgroup that benefits from adjuvant chemo intensification (oxaliplatin-doublet vs observation, pending randomized confirmation). Emerging evidence in muscle- invasive bladder (IMvigor010 ctDNA subgroup, atezolizumab benefit restricted to ctDNA+), early breast (c-TRAK-TN, talazoparib re- initiation), early NSCLC (LIBRETTO-001 surveillance), and resected HR+ breast (lead...
Клінічний напрям	investigate
Категорія	transformation-progression

Логіка спрацьовування

{
  "any_of": [
    {
      "finding": "ctdna_mrd",
      "value": "positive"
    },
    {
      "finding": "ctdna_mrd_status",
      "value": "positive"
    },
    {
      "finding": "ctdna_mrd_post_treatment",
      "value": "positive"
    },
    {
      "finding": "ctdna_mrd_signatera",
      "value": "positive"
    },
    {
      "finding": "ctdna_mrd_tumor_informed",
      "value": "positive"
    },
    {
      "finding": "ctdna_mrd_call",
      "value": true
    },
    {
      "comparator": ">",
      "finding": "ctdna_mtm_per_ml",
      "threshold": 0
    }
  ],
  "type": "biomarker"
}

Нотатки

**Why pan-tumor:** ctDNA-MRD positivity is a lineage-agnostic post- treatment risk-stratification signal — the underlying assay technology and recurrence-hazard pattern reproduce across CRC (GALAXY), bladder (IMvigor010 retrospective), early breast (c-TRAK-TN, ZEST), early NSCLC, esophagogastric (CRITICS-II), HCC (post-resection liquid surveillance), and pancreatic (post-Whipple Signatera pilot data). The MVP wiring is "investigate" — surveillance-cadence escalation + trial-eligibility surface — not direct algorithm-branching, because: - Adjuvant-chemo intensification on ctDNA+ alone is NOT yet RCT- proven (CIRCULATE-Japan ALTAIR, GALAXY randomized step, COBRA, are in flight; first-readout phase 3 confirmation pending). - Switching adjuvant from observation to chemo solely on ctDNA+ without biopsy/imaging confirmation risks over-treatment of false- positive calls (~5-10% specificity loss in tumor-agnostic panels). - Disease-specific algorithms each have distinct intensification options (oxaliplatin-doublet in CRC, atezolizumab in bladder, PARPi in BRCA+ breast) — these belong in disease-anchored algorithm steps, not in a universal RF. **Required follow-up actions when this RF fire...

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