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The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance (TGAUS)

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ClinicalTrials.gov Identifier: NCT02329379
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : December 31, 2014
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Chiang Su, National Defense Medical Center, Taiwan

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.

Condition or disease Intervention/treatment Phase
Goiter Drug: Levothyroxine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Role of Levothyroxine on the Patients With Atypia of Undetermined Significance (AUS) Goiter
Estimated Study Start Date : May 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

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Arm Intervention/treatment
Experimental: Unigoiter, ATA (+), AUS (+) on Tx
The patients who have uninodular goiter demonstrated by thyroid sono and positive autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance will take eltroxin for TSH suppression therapy to ameliorate of goiter
Drug: Levothyroxine
Other Name: Eltroxin

Active Comparator: Unigoiter, ATA (-), AUS (+) on Tx
The patients who have uninodular goiter demonstrated by thyroid sono and negative autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance will take eltroxin for TSH suppression therapy to ameliorate of goiter
Drug: Levothyroxine
Other Name: Eltroxin

No Intervention: Unigoiter, ATA (+), AUS (+) without Tx
The patients who have uninodular goiter demonstrated by thyroid sono and positive autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance decide not to take eltroxin for TSH suppression therapy; instead, only observation with following will be conducted
No Intervention: Unigoiter, ATA (-), AUS (+) without Tx
The patients who have uninodular goiter demonstrated by thyroid sono and negative autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance decide not to take eltroxin for TSH suppression therapy; instead, only observation with following will be conducted
Experimental: Multigoiter, ATA (+), AUS (+) on Tx
The patients who have multinodular goiter demonstrated by thyroid sono and positive autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance will take eltroxin for TSH suppression therapy to ameliorate of goiter
Drug: Levothyroxine
Other Name: Eltroxin

Active Comparator: Multigoiter, ATA (-), AUS (+) on Tx
The patients who have multinodular goiter demonstrated by thyroid sono and negative autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance will take eltroxin for TSH suppression therapy to ameliorate of goiter
Drug: Levothyroxine
Other Name: Eltroxin

No Intervention: Multigoiter, ATA (+), AUS (+) without Tx
The patients who have multinodular goiter demonstrated by thyroid sono and positive autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance decide not to take eltroxin for TSH suppression therapy; instead, only observation with following will be conducted
No Intervention: Multigoiter, ATA (-), AUS (+) without Tx
The patients who have multinodular goiter demonstrated by thyroid sono and negative autoantibody of thyroglobulin with pathological reports of fine needle aspiration showing atypical undetermined of significance decide not to take eltroxin for TSH suppression therapy; instead, only observation with following will be conducted



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

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


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329379


Sponsors and Collaborators
Sheng-Chiang Su
Investigators
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Principal Investigator: Sheng-Chiang Su Tri-Service General Hospital National Defense Medical Center

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Responsible Party: Sheng-Chiang Su, Attending Physician, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT02329379     History of Changes
Other Study ID Numbers: 1-103-05-081
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Goiter
Thyroid Diseases
Endocrine System Diseases