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Thyroid and Neck Ultrasound in Identifying Genomic Predictors of Tumor Progression in Patients with Thyroid Cancer
Trial Status: active
This research trial studies thyroid and neck ultrasound in identifying genomic predictors of tumor progression in patients with thyroid cancer. Thyroid and neck ultrasound may help identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.
Inclusion Criteria
Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist
Being followed with active surveillance at MSKCC
Biopsied index nodule less than or equal to 2 cm in maximum dimension
Thyroid and neck ultrasound (US) performed and interpreted by a MSKCC radiologist within 6 months prior to study entry
Exclusion Criteria
Biopsied index nodule greater than 2 cm in any dimension
Additional locations may be listed on ClinicalTrials.gov for NCT02363595.
I. To implement a prospective observation protocol that will accurately classify tumors as either stable or progressive over time during a period of active surveillance.
II. To implement a prospective observation protocol that will provide permission to obtain papillary microcarcinomas (PMC) samples that are surgically removed after a period of active surveillance.
III. To validate a molecular risk classifier that was developed from a retrospective analysis of paraffin embedded archival PMC samples and explore the potential for improving it using massively parallel exon sequencing of the cancer genes and global gene expression profiling on fresh frozen PMC samples obtained at thyroidectomy after a period of active observation.
SECONDARY OBJECTIVES:
I. To describe the likelihood of disease progression (growth of primary tumor or development of loco-regional/distant metastases) in a series of PMC patients followed with active surveillance in the United States.
II. To describe the likelihood of PMC patients opting for surgical resection without evidence of disease progression while in an active surveillance program.
III. To describe clinico-pathologic features associated with disease progression in PMC patients followed with active surveillance.
OUTLINE:
Patients undergo standard of care thyroid and neck ultrasound every 6-18 months.
After completion of study, patients are followed up indefinitely.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center