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Targeted-sequencing of PTC in Different Stages

Sponsor
Shanghai 6th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03214978
Collaborator
(none)
80
Enrollment
5.1
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Targeted-sequencing of PTC in Different Stages
    Anticipated Study Start Date :
    Jul 30, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2017
    Anticipated Study Completion Date :
    Dec 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. types of mutation of targets genes in papillary thyroid carcinomas in different stages [2018-1-1]

      types of mutation of targets genes in papillary thyroid carcinomas in different stages

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who will receive thyroid resection
    Exclusion Criteria:
    • patients who has been radiologically treated

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai 6th People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LI Yi, Doctor, Shanghai 6th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03214978
    Other Study ID Numbers:
    • LY-US-THY-001
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Jul 12, 2017
    Last Verified:
    Jul 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LI Yi, Doctor, Shanghai 6th People's Hospital
    thyroid

    Study Results

    No Results Posted as of Jul 12, 2017