Goiter Clinical Trial
— TGAUSOfficial title:
Therapeutic Role of Levothyroxine on the Patients With Atypia of Undetermined Significance (AUS) Goiter
Verified date | August 2019 |
Source | National Defense Medical Center, Taiwan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sheng-Chiang Su |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with reduced goiter volume under sono >15% | 2 years | ||
Primary | Number of participants with fine-needle aspiration cytology: benign*2 times | 2 years | ||
Secondary | Number of participants need to receive operation for thyroidectomy due to malignant potentials | 2 years |
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