Recruiting

NCT Number: NCT02363595

Genomic Predictors of Papillary Microcarcinoma Disease Progression

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.

Recruiting

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Key information

Conditions

Papillary Microcarcinoma Papillary Thyroid Microcarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Michael Berger, PhD

CONTACT

646-888-3386

Robert Tuttle, MD

CONTACT

646-888-2716

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

estimate the disease progression rate

Time frame: 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%).

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Berger, PhD

CONTACT

646-888-3386

Robert Tuttle, MD

CONTACT

646-888-2716

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Ohio State University
University of Pittsburgh

Registry information

Important dates

Study start: 2014
Primary completion: 2027
Study completion: 2027
First posted: Feb 16, 2015
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed