Genomic Predictors of Papillary Microcarcinoma Disease Progression

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02363595

Enrollment

750

Registered

2015-02-16

Start date

2014-12-31

Completion date

2027-12-31

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Microcarcinoma

Keywords

Genomic Predictors, 14-277

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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%).

Countries

United States

Contacts

CONTACTRobert Tuttle, MD

646-888-2716

CONTACTMichael Berger, PhD

646-888-3386

PRINCIPAL_INVESTIGATORRobert Tuttle, MD

Memorial Sloan Kettering Cancer Center

Outcome results