Active Surveillance for Low-risk Papillary Thyroid Carcinoma

NCT06261190 | Enrolling By Invitation

• 1 other identifier: H-2308-182-1463
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.

Conditions

Thyroid Cancer; Papillary Thyroid Carcinoma

Keywords

Active Surveillance; Immediate surgery

Outcome Measures

Primary Outcomes (1)

• Rate of disease progression between the active surveillance group and the immediate surgery group

  Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.

  At 5years, 10years after enrollment

Secondary Outcomes (6)

• Risk factors for disease progression in the active surveillance group

  At 5years, 10years after enrollment

• Rate of conversion to surgery without disease progression in the active surveillance group

  At 5years, 10years after enrollment

• Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group

  At 5years, 10years after enrollment

• Factors influencing treatment decision-making

  At 5years, 10years after enrollment

• Decision Conflict Scale Score

  For the first 2 years, every 6 months, then every 6-12 months depending on the condition.

Study Arms (2)

Active surveillance

Group with active surveillance of their Papillary Thyroid Cancer

Immediate surgery

Group who underwent surgery after diagnosis Papillary Thyroid Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center.

You may qualify if:

• subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
• subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.

You may not qualify if:

• subjects who are unable or unwilling to attend regular follow-ups..
• subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Seoul National University Hospital: collaborator

Study Sites (4)

National Cancer Center

Goyang-si, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

SMC-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: March 6, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

KR (4)