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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05395429

Enrollment

1000

Registered

2022-05-27

Start date

2022-03-25

Completion date

2023-12-15

Last updated

2023-02-23

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

Conditions

Thyroid Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
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.	2 months

Countries

China

Contacts

Primary ContactYanjun Zheng, PhD

yanjun.zheng@genetronhealth.com1861352256129

Outcome results