NCT02609685

Active Surveillance of Papillary Thyroid Microcarcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

Detailed description

The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise. The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States. Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.

Conditions

• Papillary Thyroid Microcarcinoma

Interventions

Type	Name	Description
OTHER	Active Surveillance	Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.

Timeline

• Start date: 2016-05-13
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2015-11-20
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States