Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients

Genetron Health

Status: Unknown

Conditions: Thyroid Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05395429

20210155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with clinical diagnosis of suspected thyroid cancer who underwent fine-needle aspiration (FNA)
2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
3. Subjects who can provide a complete FNA sample
4. Subjects who agree to provide follow-up diagnosis and treatment information

Exclusion criteria

1. 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.
2. Samples with incomplete information required.
3. The amount of DNA extracted is not enough to complete the samples tested by the assessment reagent or comparative method.

Trial design