Genomic Predictors of Papillary Microcarcinoma Disease Progression

Recruiting

• Conditions: Papillary Microcarcinoma

• Registration Number: NCT02363595
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?

Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-31
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.

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Exclusion Criteria

• Biopsied index nodule greater than 2 cm in any dimension
• Age less than 18 yrs old

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
estimate the disease progression rate	4 years	Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%).

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States