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A novel minimal residual disease (MRD) detection technology integrating DNA mutation and methylation analysis predicts postoperative recurrence risk in esophageal cancer

A novel minimal residual disease (MRD) detection technology integrating DNA mutation and methylation analysis predicts postoperative recurrence risk in esophageal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106785
Enrollment
Unknown
Registered
2025-07-30
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Esophageal cancer

Interventions

Recurrence and metastasis group:MRD-positive
Recurrence/metastasis-free group:MRD-negative

Sponsors

HenanCancerHospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Provision of signed informed consent and age >18 years; 2.Esophageal squamous cell carcinoma confirmed by histology or cytology, without considering any mutation characteristics of the patient; 3.Patients can be diagnosed with esophageal cancer that can be treated with curative surgery; 4.Patients can provide remaining paraffin embedded tumor tissue samples (FFPE) or fresh tissue samples collected from the biological sample center during the same period of diagnosis and treatment, and cooperate with the collection of peripheral blood at various nodes; 5.No other anti-tumor treatments have been performed in the past; 6.Patient PS score 0-2; 7.Provide clinical pathological and imaging data required for the research process in conjunction with the treatment process;

Exclusion criteria

Exclusion criteria: 1.Patients with previous malignant tumors are not eligible to participate in the study unless they have achieved complete remission for at least 5 years prior to enrollment and do not require any other treatment or do not require any other treatment during the study period; 2.The patient has severe anemia; 3.Incomplete subject related information; 4.Pregnant, preparing for pregnancy or breastfeeding women; 5.Individuals with a history of severe mental illness; 6.The patient receives a blood transfusion two weeks before or during the surgical resection; 7.The patient has any other conditions that the researchers believe may interfere with the subject's assessment; 8.Unable to follow up with the study according to the determined clinical follow-up period; 9.Unable to accept or provide designated efficacy evaluation methods such as imaging;

Design outcomes

Primary

MeasureTime frame
Recurrence Rate in MRD+;Recurrence-Free Survival(RFS);

Secondary

MeasureTime frame
Consistency between MRD and traditional monitoring methods;MRD Clearance Rate;The interval between the occurrence time of MRD positivity and the recurrence time;Sensitivity and specificity of comprehensive treatment response index in predicting recurrence;MRD in each subgroup predicts the efficacy of recurrence and metastasis;Sensitivity and specificity of MRD in predicting recurrence;

Countries

China

Contacts

Public ContactWei Bing

Henan Cancer Hospital

1140881981@qq.com+86 371 6558 7578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026