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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
216
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGRate of disease progression
Time frame: From time of diagnosis up to10 years of follow-up
Percentage of subjects that will elect surgery despite absence of clinical progression
Time frame: From time of diagnosis up to 10 years of follow-up
Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound
Time frame: Five years
Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance
Time frame: Five years
Identify the genetic factors associated with an increased risk of disease progression
At any time subjects who have enrolled in the active surveillance study can opt to have surgery. Data will be taken from diagnosis to just after surgery.
Time frame: Five years
Quality of life score as measured by City of Hope Quality of Life Scale
Time frame: Up to five years
Anxiety score as measured by Memorial Anxiety Scale
Time frame: Up to five years
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