Genomic Predictors of Papillary Microcarcinoma Disease Progression

Papillary Microcarcinoma Clinical Trial

Official title:

Genomic Predictors of Papillary Microcarcinoma Disease Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363595
• Other study ID #: 14-277
• Status: Recruiting
• Start date: December 31, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Robert Tuttle, MD
• Phone: 646-888-2716
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Biopsied index nodule greater than 2 cm in any dimension

• Age less than 18 yrs old

Related Conditions & MeSH terms

• Disease Progression
• Papillary Microcarcinoma
• Thyroid Neoplasms

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Ohio State University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimate the disease progression rate	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%).	4 years

External Links

•   Memorial Sloan Kettering Cancer Center