A Study to Collect Information About the Use of Redifferentiating Medications as a Standard Treatment for Thyroid Cancer

April 22, 2026 updated by: Memorial Sloan Kettering Cancer Center

Outcomes of Patients With Thyroid Carcinoma Treated With Redifferentiating Agents as Part of Routine Clinical Care: A Prospective Data Collection Study

The purpose of this study to learn more about the use of redifferentiating medications as a standard treatment for radioactive iodine/RAI-refractory thyroid cancer. This study is a registry study.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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: Alan Ho, MD, PhD
  • Phone Number: 646-608-3774
  • Email: hoa@mskcc.org

Study Contact Backup

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Laura Boucai, PhD
          • Phone Number: 646-608-3906

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 patients eligible to receive a redifferentiating agent in the adjuvant setting or in the treatment of structural metastatic disease not enrolled in a clinical trial will be approached for recruitment. All eligible patients will enroll in the study and will be followed indefinitely after enrollment.

Description

Inclusion Criteria:

  • Patients ≥ 18 years old at time of consent

Inclusion Criteria:

  • Patients diagnosed with RAI refractory thyroid cancer or unlikely to respond to RAI.
  • Patients who will receive redifferentiation agents prior to planned diagnostic and/or therapeutic use of radioactive iodine as part of routine clinical care.
  • Patients who have never received redifferentiation agents outside of a clinical trial or have received redifferentiation agents in the context of a clinical trial will be enrolled after the clinical team has decided to proceed with a redifferentiation agent as part of routine clinical care prior to diagnostic and/or therapeutic radioactive iodine administration.
  • Patients previously treated with redifferentiation agents as part of clinical care prior to diagnostic and/or therapeutic radioactive iodine administration who are willing to provide retrospectively collected data surrounding the time of the previous treatment and will provide prospective data from the time of consent.

Exclusion Criteria:

  • RAI refractory thyroid cancer patients that will receive redifferentiation agents prior to diagnostic and/or therapeutic use of radioactive iodine as part of a prospective clinical trial.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with refractory thyroid cancer patients
Follow-up visits will be carried out at intervals per usual clinical practice. Tolerance of medication and adverse events will be recorded in every visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events will be collected in every visit
Time Frame: 2 years
The primary objective of this protocol is to prospectively collect data on patients with radio-iodine refractory thyroid cancer or patients unlikely to respond to radioactive iodine prior, during and after initiation of redifferentiating agents used as part of routine clinical care with or without radioactive iodine treatment.
2 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Laura Boucai, 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.

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)

February 7, 2023

Primary Completion (Estimated)

February 7, 2028

Study Completion (Estimated)

February 7, 2028

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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