Genomic Predictors of Papillary Microcarcinoma Disease Progression

December 7, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Robert Tuttle, MD
  • Phone Number: 646-888-2716

Study Contact Backup

  • Name: Michael Berger, PhD
  • Phone Number: 646-888-3386

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Robert Tuttle, MD
          • Phone Number: 646-888-2716
        • Contact:
          • Michael Berger, PhD
          • Phone Number: 646-888-3386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All papillary thyroid cancer patients evaluated at MSKCC clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of Pittsburgh
Ohio State University

Investigators

  • Principal Investigator: Robert Tuttle, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2014

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimated)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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