Long Period Observation of Biochemical Survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02868476
Collaborator
(none)
532
95.3

Study Details

Study Description

Brief Summary

Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future.The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Clinical and subclinical thyroid disease is usually used to describe patients with mild symptoms correlated to hyperthyroid or hypothyroid state. Thyroid ultrasonography could differentiate benign or malignant nodular lesion, together with fine needle aspiration cytology and surgical pathology. Thyrotropin (TSH, thyroid stimulating hormone) is the pivotal investigation in laboratory diagnosis to define subclinical thyroid diseases. An elevated TSH with normal free thyroxine and triiodothyronine levels in serum is defined to be subclinical hypothyroidism, and a subnormal TSH with normal thyroid hormone concentrations to be subclinical hyperthyroidism. Generally, the prevalence of subclinical hypothyroidism and hyperthyroidism were reported as 4% -10% & 1%-2% in general population, respectively. Although subclinical thyroid disease is prevalent, there is still no consensus for screening clinical and subclinical thyroid disease, including hyperthyroidism, hypothyroidism, nodular goiter and thyroid cancer. Under consideration of age, gender or familial history of autoimmune thyroid disease. However, screening for thyroid dysfunction should be considered in some high risk patients, including 1) elderly; 2) history of atrial fibrillation; 3) previous thyroid disease history; 4) other confirmed autoimmune diseases; 5) neck exposure of radiation (for example, nasopharyngeal cancer, post-radiation); 6) family history of probable autoimmune thyroid disease, and 7) pregnant state with prior thyroid disease history. Therapeutic decision for clinical and subclinical thyroid dysfunction should be considered individually. Therapeutic options will be anti-thyroid medications and/or radioactive iodine, and thyroidectomy could be considered with larger goiters for hyperthyroidism. For clinical and subclinical hypothyroidism, the therapeutic consideration should be aimed on reduction of progression to overt hypothyroidism, improving heart function, correction of dyslipidemia, and relieving senescence depressive mood. Thyroid ultrasonography will help us to keep long term observation of thyroid structural change. But long term outcome for treatment of such functional and structural thyroid diseases had not been recorded delicately in Taiwan. Further investigations should be observed in the future. We hope to check the relationship between various thyroid diseases and biochemical survey/ultrasonography. The purpose of this study is aiming for early prevention and detection the potential risk factors for thyroid diseases in Taiwan.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    532 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long Period Observation of Biochemical Survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases
    Actual Study Start Date :
    Aug 19, 2016
    Actual Primary Completion Date :
    May 26, 2017
    Anticipated Study Completion Date :
    Jul 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Long Period Observation of Biochemical survey and Ultrasonography in Thyroid Diseases and Subclinical Thyroid Diseases [5 years]

      The study was designed as prospective pattern, and the investigators enrolled new patients with hyperthyroidism/hypothyroidism/nodular goiter/thyroid cancer with long period follow-up, then record thyroid change of thyroid function after treatment of anti-thyroid drugs or thyroid hormone replacement; the clinical outcome of nodular goiter with serial fine needle aspiration cytology and the correlation with thyroid ultrasonography, with the volume/echogenicity/vascularity of nodular goiters. Try to find the correlation of outcome (including how long will the anti-thyroid drugs be stopped without thyroid ablation, the natural course of benign nodular goiters without operation; or thyroid cancer recurrence, thyroid cancer, lymph nodes metastasis or distant metastasis, with surgery/radioactive iodine ablation/target therapy) with regular follow-up in outpatient department via time-dependent manner at least 5 years.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 20-80 years old

    • Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years.

    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: CHIH-YUAN WANG, Doctor, Department of Internal Medicine, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02868476
    Other Study ID Numbers:
    • 201606056RINA
    First Posted:
    Aug 16, 2016
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022