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

NCT ID: NCT05395429

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-25

Study Completion Date

2023-12-15

Brief Summary

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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

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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.

Conditions

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Thyroid Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Yunnan Cancer Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Genetron Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, , China

Site Status RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, , China

Site Status RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status RECRUITING

Yunnan Cancer Hospital

Yunnan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanjun Zheng, PhD

Role: CONTACT

1861352256129

Facility Contacts

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Weiming lv

Role: primary

13925177549

Jian Qin

Role: primary

86-13888578970

Ming Gao

Role: primary

86-13820881516

Yongchun Zhou

Role: primary

13398844906

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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20210155

Identifier Type: -

Identifier Source: org_study_id

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