Los Angeles, California 90048


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma - 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


NCT ID:

NCT02609685


Primary Contact:

Principal Investigator
Allen Ho, MD
Cedars-Sinal Medical Center

Allen Ho, MD
Phone: 310-423-1220
Email: Allen.Ho@cshs.org


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90048
United States

Allen Ho, MD
Phone: 310-423-1220
Email: Allen.Ho@cshs.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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