The Role of Levothyroxine on Goiter With Atypia of Undetermined Significance

NCT02329379 | Withdrawn Phase 4

• 1 other identifier: 1-103-05-081
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (2)

• Number of participants with reduced goiter volume under sono >15%

  2 years

• Number of participants with fine-needle aspiration cytology: benign*2 times

  2 years

Secondary Outcomes (1)

• Number of participants need to receive operation for thyroidectomy due to malignant potentials

  2 years

Study Arms (8)

Unigoiter, ATA (+), AUS (+) on Tx

EXPERIMENTAL

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

Unigoiter, ATA (-), AUS (+) on Tx

ACTIVE COMPARATOR

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

Unigoiter, ATA (+), AUS (+) without Tx

NO INTERVENTION

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

Unigoiter, ATA (-), AUS (+) without Tx

NO INTERVENTION

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

Multigoiter, ATA (+), AUS (+) on Tx

EXPERIMENTAL

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

Multigoiter, ATA (-), AUS (+) on Tx

ACTIVE COMPARATOR

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

Multigoiter, ATA (+), AUS (+) without Tx

NO INTERVENTION

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

Multigoiter, ATA (-), AUS (+) without Tx

NO INTERVENTION

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

Interventions

Levothyroxine DRUG

Also known as: Eltroxin

Multigoiter, ATA (+), AUS (+) on Tx; Multigoiter, ATA (-), AUS (+) on Tx; Unigoiter, ATA (+), AUS (+) on Tx; Unigoiter, ATA (-), AUS (+) on Tx

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• all patients without definite goiter
• all patients with major illness as CAD, DM or CVA (CerebroVascular Accident)
• all patients with pregnancy or malignancy

Sponsors & Collaborators

• Sheng-Chiang Su: lead

MeSH Terms

Conditions

Goiter

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sheng-Chiang Su

  Tri-Service General Hospital National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: May 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: August 21, 2019

Record last verified: 2019-08