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Human BRAF/TERT/CCDC6-RET gene diagnosis kit (qPCR method) clinical trial

Human BRAF/TERT/CCDC6-RET gene diagnosis kit (qPCR method) clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065365
Enrollment
Unknown
Registered
2022-11-03
Start date
2022-11-07
Completion date
Unknown
Last updated
2023-05-15

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:The test results of the assessment reagent were compared and analyzed with the Sanger sequencing test results to evaluate the clinical accuracy of the assessment reagent. At the same tim
Index test:Evaluation index of assessment reagent and Sanger sequencing method: (1) Positive compliance rate and its 95% CI
(2) Negative compliance rate and its 95% CI
(3) Total agreement rate and its 95% CI
(4) Kappa value. Evaluation indicators of assessment reagents and clinical comprehensive diagnosis or histopathological diagnosis: (1) Sensitivity and 95%CI
(2) Specificity and 95%CI
(3) Accuracy and 95%CI
(4) Kappa value.

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Comprehensive clinical diagnosis information or histopathological results are available; 2. The cytopathological results after fine needle puncture meet one of the following requirements: (1) The benign and malignant thyroid nodules (Bethesda III, V) can not be determined; (2) Patients with thyroid nodules that cannot be identified as benign or malignant (Bethesda IV); (3) Identify patients with malignant (Bethesda VI) thyroid nodules; (4) Identify patients with benign (Bethesda Class II) thyroid nodules.

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 do not meet any of the criteria for inclusion; 5. Samples that the researchers think need to be excluded.

Design outcomes

Primary

MeasureTime frame
Gene mutation;Positive coincidence rate and 95% CI;Negative coincidence rate and 95% CI;Total compliance rate and 95% CI;sensitivity;Specificity;accuracy;

Countries

China

Contacts

Public ContactLiu Zhiyan

Shanghai Sixth People's Hospital

215872177@qq.com+86 18930172295

Outcome results

None listed

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