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A study of ctDNA methylation for minimal residual disease detection in locally advanced esophageal squamous cell carcinoma

Performance validation and clinical application of tumor-naïve ctDNA methylation assay in locally advanced resectable esophageal squamous cell carcinoma: a prospective, observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128941
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

progressive dysphagia

Interventions

ctDNA-positive group:None
ctDNA-negative group:None

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed resectable locally advanced ESCC, stage T2N+M0 or T3-4aN0/+M0; 2. Aged >=18 years; 3. Received neoadjuvant therapy (paclitaxel + platinum + PD-1 inhibitor, 2-3 cycles) and achieved R0 resection; 4. Can tolerate adjuvant therapy post-surgery (2-3 cycles chemo-immunotherapy + maintenance immunotherapy up to 1 year); 5. Adequate tissue and peripheral blood samples available for testing; 6. ECOG performance status 0-1; 7. Adequate major organ function; 8. Signed informed consent and ability to comply with the study protocol; 9. Expected post-surgery survival >= 6 months.

Exclusion criteria

Exclusion criteria: 1. History of other concurrent or prior malignancies; 2. Lack of detailed histopathological report; 3. History of allogeneic organ or stem cell transplantation, or blood transfusion within 6 months before enrollment; 4. Unable to provide post-surgical landmark (1-6 weeks post-op, before adjuvant therapy) samples or technical failure of sample testing; 5. Pregnant or lactating women; 6. Other conditions deemed unsuitable by the investigator.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival rate;

Secondary

MeasureTime frame
Overall survival (OS);Disease-free survival (DFS);Lead time of ctDNA monitoring;Sensitivity of ctDNA assay;Specificity of ctDNA assay;

Countries

China

Contacts

Public ContactMiao Jinbai

Beijing Chao-Yang Hospital, Capital Medical University

miaojinbai@163.com+86 10 85231044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026