Clinical Trial: The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Therapeutic Role of Levothyroxine on the Patients With Atypia of Undetermined Significance (AUS) Goiter

Brief 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.

Detailed Summary:

The prevalence of goiter in Taiwanese adults was found to be 19.4% in males, 33.6% in females and 25% in total about 20 years ago even though there was no iodine-deficient area reported in Taiwan. The result implied that goiter not only became a quite common disorder, but also deserved further investigation, particularly since 0.7% of goiter would be diagnosed as thyroid cancers by means of fine-needle aspiration (FNA). However, the recent research indicated 5-15% of results after fine-needle aspiration directly disclosed malignant cytology. On the other hand, about 80% of initial results of FNA would appear non-malignant cytology. The most common feature of them was found to be indeterminate cytology, which refers to 15-30% of FNA specimens. The indeterminate cytology included follicular or Hurthle cell neoplasm as well as atypia of undetermined significance (AUS). Based on the revised American Thyroid Association Management Guidelines for Patients with Thyroid Nodules, people would be referred to visit surgeons for surgical intervention if their reports of FNA demonstrated either Hurthle cell neoplasm or follicular neoplasm without autonomously functioning nodules; instead, population with AUS goiter only received observation for a period of time for following. Otherwise, they would be arranged to undergo surgical manipulations if any evidence of malignancy was suspected. There has been lack of sufficient studies to offer therapeutic options for the patient with AUS goiter around the world up to the present, especially in Taiwan. Therefore, in order to avoid unnecessary operation performed upon the patient with AUS goiter and provide another effective treatment for them, a well-designed, prospective clinical trial will be warranted on the patient with AUS goiter.

To achieve the goal, the pathophysiology of goiter required to be understood at first. Although the actual e
Sponsor: Sheng-Chiang Su

Current Primary Outcome:

  • Number of participants with reduced goiter volume under sono >15% [ Time Frame: 2 years ]
  • Number of participants with fine-needle aspiration cytology: benign*2 times [ Time Frame: 2 years ]


Original Primary Outcome:

  • reduced goiter volume under sono >15% [ Time Frame: 2 years ]
  • cytology: benign*2 times [ Time Frame: 2 years ]


Current Secondary Outcome: Number of participants need to receive operation for thyroidectomy due to malignant potentials [ Time Frame: 2 years ]

Original Secondary Outcome: operation for thyroidectomy due to malignant potentials [ Time Frame: 2 years ]

Information By: National Defense Medical Center, Taiwan

Dates:
Date Received: December 29, 2014
Date Started: May 2015
Date Completion: December 2016
Last Updated: April 13, 2015
Last Verified: April 2015