Status:

UNKNOWN

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

Lead Sponsor:

Genetron Health

Collaborating Sponsors:

Tianjin Medical University Cancer Institute and Hospital

First Affiliated Hospital, Sun Yat-Sen University

Conditions:

Thyroid Cancer

Eligibility:

All Genders

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 25 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 15 2023

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT05395429

Start Date

March 25 2022

End Date

December 15 2023

Last Update

February 23 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

2

First Affiliated Hospital of Kunming Medical University

Kunming, China

3

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

4

Yunnan Cancer Hospital

Yunnan, China