Active Surveillance of Papillary Thyroid Microcarcinoma
Active Surveillance of Papillary Thyroid Microcarcinoma
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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