NCT05733013

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2023Feb 2028

Study Start

First participant enrolled

February 7, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2028

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

February 8, 2023

Last Update Submit

April 22, 2026

Conditions

Keywords

RAI refractory thyroid cancerthyroid cancerthyroidRefractory Thyroid CancerRadio-iodine refractory thyroid cancer22-320Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Adverse events will be collected in every visit

    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

Study Arms (1)

Participants with refractory thyroid cancer patients

Other: Surveillance Visit

Interventions

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.

Participants with refractory thyroid cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients ≥ 18 years old at time of consent
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Study Officials

  • Laura Boucai, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Boucai, MD

CONTACT

Alan Ho, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
100 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

February 7, 2023

Primary Completion (Estimated)

February 7, 2028

Study Completion (Estimated)

February 7, 2028

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations