Genomic Predictors of Papillary Microcarcinoma Disease Progression

NCT02363595 | Recruiting

• 1 other identifier: 14-277
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Microcarcinoma

Keywords

Genomic Predictors; 14-277

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Papillary Microcarcinoma

This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All papillary thyroid cancer patients evaluated at MSKCC clinic.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Ohio State University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Study Officials

• Robert Tuttle, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Tuttle, MD

CONTACT

646-888-2716

Michael Berger, PhD

CONTACT

646-888-3386

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 16, 2015
• Study Start: December 31, 2014
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)