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A Multicenter randomized controlled study for assessing the usefulness of suppressing Thyroid Stimulating Hormone Target Levels after thyroid lobectomy in low to intermediate risk thyroid cancer patients.

A Multicenter randomized controlled study for assessing the usefulness of suppressing Thyroid Stimulating Hormone Target Levels after thyroid lobectomy in low to intermediate risk thyroid cancer patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004989
Enrollment
2986
Registered
2020-05-06
Start date
2020-05-14
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : During the five-year study intervention period, thyroid hormone (oral administration) supplementary doses are determined according to a dose-adjustment protocol established for each group's tar

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patients with histological confirmation of papillary thyroid cancer* * Papillary thyroid cancer (TNM(tumor, node, and metastasis) stage is evaluated according to the 8th edition of AJCC(American Joint Committee on Cancer)/UICC(The Union for International Cancer Control) TNM(tumor, node, and metastasis) staging system (2017)) -Maximum tumor diameter = 4 cm -Extrathyroidal extension: No invasion of adjacent organs(nerves, vascular, trachea, etc) -Node stage: Clinical N0, N1a • Patients who will receive thyroid lobectomy, or who received thyroid lobectomy within previous 3 weeks • Non-pregnant women of childbearing potential (confirmed by medical history taking) • Ages 19 to 80 (less than 80) • If there are nodules in the opposite lobe: Thyroid nodules are evaluated by ultrasound (based on K-TIRADS(Korean Thyroid Imaging Reporting and Data System)). Bethesda classification criteria 1-3 if the fine needle aspiration test is indicated

Exclusion criteria

Exclusion criteria: • The following patients in the postoperative findings -pT4, pN1b or M1 - PTC with Aggressive histological features : diffuse sclerosing variant -Other types of thyroid cancer (follicular, poorly differentiated, anaplastic, or medullary thyroid cancer) • Completion thyroidectomy is required • Residual disease present(R1/ R2 resection) • No proper evaluation of nodules located in the contralateral lobe, or Bethesda classification criteria 4-6 in the result of fine needle aspiration test • Hyperthyroidism

Design outcomes

Primary

MeasureTime frame
Relapse-free survival

Secondary

MeasureTime frame
Disease free survival;Disease specific survival;Target-TSH-level achievement rate;The incidence of cardiovascular and metabolic complications (cardiovascular disease, Arrhythmia, hypercholesterolemia, fatty liver, etc.);The incidence of musculoskeletal complications (fracture, bone density reduction, sarcopenia);The incidence of psychiatric complications (lower quality of life, affective disorder, etc.);Cost analysis (related medical expenses, loss of productivity);predictors of recurrence;predictors of cardiovascular complications;predictors of musculoskeletal complications;predictors of psychiatric complications;predictors of TSH levels and proper thyroid hormone dosage;Genetic susceptibility (Consider secondary analysis);Test interval for efficient diagnosis of recurrence

Countries

Korea, Republic of

Contacts

Public ContactEunKyung Lee

National Cancer Center

eklee@ncc.re.kr+82-31-920-1743

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026