The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance

• Status: Withdrawn
• Trial end date: 2015-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheng-Chiang Su

Criteria

Inclusion Criteria:

• all patients who presented with goiter proven by thyroid sono in euthyroid status without other preexisting major disorders and possible thyroid related symptoms, such as unexplained body weight loss with increased appetite, palpitation, hand tremors, neck swelling, hoarseness and abnormal sensation over throat.

Exclusion Criteria:

• all patients without definite goiter

• all patients with major illness as CAD, DM or CVA (CerebroVascular Accident)

• all patients with pregnancy or malignancy