Exploratory StudyPTCNCT03214978
Targeted-sequencing of PTC in Different Stages
An observational study of Exploratory Study, run by Shanghai 6th People's Hospital.
Trial summary
The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. Therefore, to recognize which PTMC is of strong progressive potential which should be operated is very crucial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exploratory Study
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2017to 31 Dec 2017
- 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: DNA will be extracted from of 40 pairs tumor samples including 40 patients in 4 groups (stage I, II, III and IV)
Who may be able to join
- patients who will receive thyroid resection
Who cannot join
- patients who has been radiologically treated
About this study
The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. Therefore, to recognize which PTMC is of strong progressive potential which should be operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells which could be used in genetic analysis. To date, there is no specific way to evaluate the aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate those mutations, a target region sequencing will be done in 40 pairs tumor samples. And ultimately to find out which genetic event could contribute to strong aggressive potential of PTC. The mutations details would be design to test the FNA and tissue sample to validate if the genetic testing based on FNA is reliable. The gene test results would be evaluated with sonographic features to predict the potential of small thyroid carcinoma before surgery. This project won't aim to study the function and mechanism of specific genes but just screen them out. So, the fund would cover the fee of the whole study and this study is very likely to achieve the goal.
- Conditions
- Exploratory Study
- Keywords
- thyroid
- Medical subject headings
- Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
types of mutation of targets genes in papillary thyroid carcinomas in different stages
types of mutation of targets genes in papillary thyroid carcinomas in different stages
Measured: 2018-1-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start30 Jul 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exploratory StudyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI Yi, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214978
- Sponsor's protocol ID
- LY-US-THY-001
- Acronym
- PTC
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted-sequencing of PTC in Different Stages
- ClinicalTrials.gov ID
- NCT03214978
- Acronym / sponsor ID
- PTC / LY-US-THY-001
- Conditions
- Exploratory Study
- Keywords
- thyroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 30 Jul 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 12 Jul 2017 (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 prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. Therefore, to recognize which PTMC is of strong progressive potential which should be operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells which could be used in genetic analysis. To date, there is no specific way to evaluate the aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate those mutations, a target region sequencing will be done in 40 pairs tumor samples. And ultimately to find out which genetic event could contribute to strong aggressive potential of PTC. The mutations details would be design to test the FNA and tissue sample to validate if the genetic testing based on FNA is reliable. The gene test results would be evaluated with sonographic features to predict the potential of small thyroid carcinoma before surgery. This project won't aim to study the function and mechanism of specific genes but just screen them out. So, the fund would cover the fee of the whole study and this study is very likely to achieve the goal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- DNA will be extracted from of 40 pairs tumor samples including 40 patients in 4 groups (stage I, II, III and IV)
Key inclusion criteria (1 listed)
- patients who will receive thyroid resection
Key exclusion criteria (1 listed)
- patients who has been radiologically treated
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
types of mutation of targets genes in papillary thyroid carcinomas in different stages
Time frame: 2018-1-1
types of mutation of targets genes in papillary thyroid carcinomas in different stages
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Exploratory Study, run by Shanghai 6th People's Hospital.
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 1 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
types of mutation of targets genes in papillary thyroid carcinomas in different stages (time frame: 2018-1-1). 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 12 Jul 2017.