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A novel MRD detection technology integrating DNA mutation and methylation analysis demonstrates predictive value for postoperative recurrence risk in non-small cell lung cancer (NSCLC)

A novel MRD detection technology integrating DNA mutation and methylation analysis demonstrates predictive value for postoperative recurrence risk in non-small cell lung cancer (NSCLC)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109628
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Non-Small Cell Lung Cancer

Interventions

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

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Patients with non-small cell lung cancer (Stage ?-?) confirmed by histology and/or cytology; 3. Patients diagnosed with non-small cell lung cancer eligible for radical surgical treatment; 4. Patients can provide residual formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from the concurrent diagnosis and treatment process, or fresh tissue samples collected by the biospecimen bank, and cooperate with the collection of peripheral blood at each time point; 5. Patients have signed the informed consent form, or the broad informed consent form, or meet the criteria for exemption from informed consent; 6. Patients can attend scheduled follow-ups, communicate well with researchers, and complete the study in accordance with the requirements.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of other malignant tumors are not allowed to participate in the study, unless they have achieved complete remission for at least 5 years before enrollment and do not require additional treatment, or will not need to receive other treatments during the study period; 2. Patients with severe anemia; 3. Incomplete information about the subjects; 4. Pregnant, planning to become pregnant, or lactating women; 5. Subjects with a history of severe mental illness; 6. Patients who received blood transfusion two weeks before surgical resection or during the surgery; 7. Patients with any other conditions that, in the investigator’s opinion, may interfere with the assessment of the subjects.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Public ContactWei Bing; Sun Haibo

HenanCancerHospital

1140881981@qq.com+86 371 65587578

Outcome results

None listed

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