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Human 4 Gene Mutation Combined Detection Kit (Combined Probe Anchoring Polymerization Sequencing Method) Clinical Trial Program

Human 4 Gene Mutation Combined Detection Kit (Combined Probe Anchoring Polymerization Sequencing Method) Clinical Trial Program

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075895
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-09-20
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Thyroid cancer

Interventions

Gold Standard:Postoperative histopathological or clinical comprehensive diagnosis.
Index test:Biomarkers: Gene mutation detection based on joint probe anchored polymerization sequencing technology.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The sample type is a fine-needle biopsy sample of thyroid nodules, which must meet any of the following requirements: (1) Patients with benign and malignant thyroid nodules (Bethesda Type III, IV and ?) could not be identified by cytopathological examination after fine needle puncture with combined histopathological/clinical diagnosis results; (2) Bethesda Type II thyroid nodule patients with benign lesions as a result of histopathological/clinical comprehensive diagnosis after surgery; (3) Postoperative histopathological findings were malignant Bethesda type VI thyroid cancer patients.

Exclusion criteria

Exclusion criteria: 1. The samples are not collected, stored and processed according to the specified requirements; 2. The sample does not meet the test requirements; 3. Repeated case samples; 4. Samples that the researchers think are not suitable for further clinical trials.

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