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The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance

NCT02329379 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-21

No results posted yet for this study

Summary

1. To elucidate the therapeutic role of levothyroxine on the patient with atypia of undetermined significance (AUS) goiter, we would design a prospective, open label and non-randomized trial to verify the therapeutic effects on goiter with AUS by means of TSH (Thyrotropin; Thyroid-Stimulating Hormone) suppression related reduction of goiter volume with subsequent alleviation of previous cytological malignant tendency. During following for 1-2 years after therapy with simultaneous monitor of possible adverse effects of levothyroxine (eltroxin), we collected blood samples and gathered all necessary data as well as performed thyroid sonography with fine-needle aspiration (FNA) for the subjects. Furthermore, we would finish our individual study for each enrolled subject if his/her condition exhibited the criteria of primary end point: reduced goiter volume under sono \>15% or cytology: benign for 2 times; operation for thyroidectomy, CAD attack, refractory arrhythmia, newly DM (Diabetes Mellitus), etc.
2. To re-evaluate the current prevalence of goiter within Taiwanese adults, we recruited all patients who presented possible thyroid related symptoms, such as unexplained body weight loss with increased appetite, palpitation, hand tremors, neck swelling, hoarseness and abnormal sensation over throat. Only the patients with goiter proven by thyroid sono in euthyroid status without other preexisting major disorders can be enrolled in our trial to undergo open label, non-randomized study.

Conditions

  • Goiter

Interventions

DRUG

Levothyroxine

Sponsors & Collaborators

  • Sheng-Chiang Su

    lead OTHER

Principal Investigators

  • Sheng-Chiang Su · Tri-Service General Hospital National Defense Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329379 on ClinicalTrials.gov