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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05395429
• Other study ID #: 20210155
• Status: Recruiting
• Start date: March 25, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2022
• Source: Genetron Health
• Contact: Yanjun Zheng, PhD
• Phone: 1861352256129
• Email: yanjun.zheng[@]genetronhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou
China	First Affiliated Hospital of Kunming Medical University	Kunming
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Yunnan Cancer Hospital	Yunnan

Sponsors (5)

Lead Sponsor	Collaborator
Genetron Health	First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University Cancer Institute and Hospital, Yunnan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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