Targeted-sequencing of PTC in Different Stages

NCT ID: NCT03214978

Last Updated: 2017-07-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exploratory Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who will receive thyroid resection

Exclusion Criteria

* patients who has been radiologically treated
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LI Yi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LY-US-THY-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.