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Recruiting
NCT02609685
Active Surveillance of Papillary Thyroid Microcarcinoma
Conditions: Papillary Thyroid Microcarcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 216
Sponsor: Cedars-Sinai Medical Center
Location: Cedars-Sinai Medical Center Los Angeles California
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02609685). StuddyBuddy aggregates publicly available trial information.