Active Surveillance of Papillary Thyroid Microcarcinoma
- Conditions
- Papillary Thyroid Microcarcinoma
- Interventions
- Other: Active Surveillance
- Registration Number
- NCT02609685
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
- Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation.
- 2.0 cm or smaller nodules by ultrasonographic criteria
- Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form
- Must be able to read and write English fluently to participate in the questionnaire portion of the study
- High-grade or poorly differentiated PTC variants
- Central or lateral neck lymphadenopathy suspicious for PTC
- Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion)
- History of radiation to neck
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Surveillance Active Surveillance Active surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter.
- Primary Outcome Measures
Name Time Method Rate of disease progression From time of diagnosis up to10 years of follow-up
- Secondary Outcome Measures
Name Time Method Percentage of subjects that will elect surgery despite absence of clinical progression From time of diagnosis up to 10 years of follow-up Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance Five years Quality of life score as measured by City of Hope Quality of Life Scale Up to five years Identify the genetic factors associated with an increased risk of disease progression Five years 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.
Anxiety score as measured by Memorial Anxiety Scale Up to five years Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound Five years
Trial Locations
- Locations (1)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States