NCT05395429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 23, 2023

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

May 24, 2022

Last Update Submit

February 22, 2023

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital sample

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

Yunnan Cancer Hospital

Yunnan, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Yanjun Zheng, PhD

CONTACT

1861352256129yanjun.zheng@genetronhealth.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

March 25, 2022

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

February 23, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)