Thyroid CancerNCT02953288
Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.
An observational study of Thyroid Cancer, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with thyroid nodule
Who may be able to join
- Patient with thyroid nodule
Who cannot join
- Coagulant function abnormality
- pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200070
About this study
To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.
Read the detailed description
In previous studies, we have found highly prevalent TERT promoter mutations in aggressive thyroid cancers. So we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign thyroid nodules | Benign thyroid nodules | |
| Thyroid Carcinoma | Thyroid Carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene sequencing
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2018 (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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Shen Qu, Study director, Sanghai Tenth People's Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953288
- Sponsor's protocol ID
- Research center of the thyroid
- Status last verified
- Nov 2016
- First submitted
- 1 Nov 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis and Clinical Treatment Strategies of Thyroid Nodules.
- ClinicalTrials.gov ID
- NCT02953288
- Acronym / sponsor ID
- Research center of the thyroid
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
To investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.
Detailed description
In previous studies, we have found highly prevalent TERT promoter mutations in aggressive thyroid cancers. So we plan to perform further research to investigate the genetic mutations of patients with thyroid carcinoma and find molecular targets for therapy.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benign thyroid nodules | – | –Benign thyroid nodules |
| Thyroid Carcinoma | – | –Thyroid Carcinoma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with thyroid nodule
Key inclusion criteria (1 listed)
- Patient with thyroid nodule
Key exclusion criteria (2 listed)
- Coagulant function abnormality
- pregnant
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
Gene sequencing
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Shen Qu study director
Sanghai Tenth People's Hospital, Shanghai, China
1 site 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 Shanghai 10th People's Hospital at 1 site 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 1 inclusion and 2 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene sequencing (time frame: 2 weeks). 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 2 Nov 2016.