Necessity of TSH Suppression Therapy in Active Surveillance for Thyroid Cancer Patients.

NCT06971965 | Not Yet Recruiting

• 1 other identifier: 2025-0173
• Study Type: interventional
• Target: 578
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter randomized controlled trial conducted in Korea. A parallel, two-group randomized design will be with thyroid stimulating hormone suppression therapy group(low TSH group; intervention) is different from the wIthout thyroid stimulating hormone (TSH) suppression therapy group(high TSH group; control).

Conditions

Thyroid Cancer; Papillary Thyroid Carcinoma

Keywords

Active Surveillance

Outcome Measures

Primary Outcomes (1)

• Rate of Disease progression

  The rate of disease progression will be assessed as the proportion (%) of patients with biopsy-confirmed recurrence, based on suspicious findings identified through thyroid (neck) ultrasound performed at 6- to 12-month intervals.

  at 3,5years after enrollment

Secondary Outcomes (10)

• Disease free survival

  at 3,5years after enrollment

• Disease specific survival

  at 3,5years after enrollment

• Overall Survival

  at 3,5years after enrollment

• Target-TSH-level achievement rate

  at 3,5years after enrollment

• Incidence of complications

  at 3,5years after enrollment

Study Arms (2)

low TSH group

EXPERIMENTAL

0.3 ≤ target TSH \<2.0mIU/L

Drug: Levothyroxin

high TSH group

EXPERIMENTAL

2.0 ≤ target TSH \<8.0mIU/L

Drug: Levothyroxin

Interventions

Levothyroxin DRUG

During the five-year study intervention period, thyroid hormone (oral administration) supplementary doses are determined according to a dose-adjustment protocol established for the group's target TSH range.

high TSH group; low TSH group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
• Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
• Non-pregnant women of childbearing potential (confirmed by medical history taking)

You may not qualify if:

• Hyperthyroidism
• If the investigator determines that you are not suitable for clinical research participation considering the following comorbidities:
• Myocardial infarction or cerebrovascular accident within the last three months.
• Diseases with limited life expectancy or potentially impairing the patient's ability to comply with at least five years of treatment or follow-up.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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

• Eun Kyung Lee

  National Cancer Center

  PRINCIPAL INVESTIGATOR

• Young Joo Park

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Minjoo Kim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Kyung Lee

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share