Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 4
- Primary Endpoint
- The main purpose of this study is: by evaluating the Genetron TERT/BRAF PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
Study Overview
Brief Summary
The purpose of this trail is to evaluate the performance of Genetron TERT/BRAF PCR Kit in Thyriod Cancer patients using real-time PCR method.
Detailed Description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron TERT/BRAF PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA)
- •The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
- •Subjects who can provide a complete FNA sample
- •Subjects who agree to provide follow-up diagnosis and treatment information
Exclusion Criteria
- •The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
- •Samples with incomplete information required.
- •The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.
Outcomes
Primary Outcomes
The main purpose of this study is: by evaluating the Genetron TERT/BRAF PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
Time Frame: 2 months
Secondary Outcomes
No secondary outcomes reported