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Human SHOX2, RASSF1A gene methylated DNA detection kit (PCR fluorescence method)

Human SHOX2, RASSF1A gene methylated DNA detection kit (PCR fluorescence method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082148
Enrollment
Unknown
Registered
2024-03-21
Start date
2024-03-31
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

lung cancer

Interventions

Gold Standard:Take pathological diagnosis or clinical auxiliary test results as the "gold standard"
Index test:Qualitative detection of human SHOX2 gene and human RASSF1A gene methylation in human sputum, alveolar lavage fluid, and pleural effusion

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: Suspected patients with lung cancer who have clinical symptoms of lung cancer (such as long-term cough, hemoptysis, chest tightness, asthma, chest and back pain, etc.) but no clear diagnosis.

Exclusion criteria

Exclusion criteria: (1) The sample is less than 25mL (including preservation solution); (2) Samples in which no cells were found after centrifugation; (3) Samples with unclear sample collection time or subject case information; (4) The sample extraction volume does not meet the testing requirements in the instruction manual (the total amount of nucleic acid is insufficient or the sample is severely degraded). (5) Samples that do not meet the basic conditions for storage of test kit samples.

Design outcomes

Primary

MeasureTime frame
Positive coincidence rate and 95% CI;Negative coincidence rate and 95% CI;Total compliance rate and 95% CI;sensitivity;Specificity;Kappa value;

Countries

China

Contacts

Public ContactZhiyan Liu

Shanghai Sixth People's Hospital

215872177@qq.com+86 189 3017 2295

Outcome results

None listed

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