Thyroid CancerNCT05395429
Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
An observational study of Thyroid Cancer, run by Genetron Health at 4 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- How many people
- 1,000 participants
- Where
- 4 sitesChina
- Study dates
- 25 Mar 2022to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital sample
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou
Weiming lv, 13925177549, lvwm@mail.sysu.edu.cn
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming
Jian Qin, 86-13888578970, kyfyygcp@sina.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Ming Gao, 86-13820881516, gaoming68@aliyun.com
- Recruiting
Yunnan Cancer Hospital
Yunnan
Yongchun Zhou, 13398844906, chungui7625@163.com
About this study
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start25 Mar 2022
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genetron Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital, Sun Yat-Sen University, Yunnan Cancer Hospital, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395429
- Sponsor's protocol ID
- 20210155
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Genetron TERT/BRAF PCR Kit in Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT05395429
- Acronym / sponsor ID
- 20210155
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Genetron HealthIndustry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital, Sun Yat-Sen University, Yunnan Cancer Hospital, First Affiliated Hospital of Kunming Medical University
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Genetron Health at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanjun Zheng, PhD (1861352256129, yanjun.zheng@genetronhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.