A Study to Collect Information About the Use of Redifferentiating Medications as a Standard Treatment for Thyroid Cancer
Outcomes of Patients With Thyroid Carcinoma Treated With Redifferentiating Agents as Part of Routine Clinical Care: A Prospective Data Collection Study
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2023
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 7, 2028
April 27, 2026
April 1, 2026
5 years
February 8, 2023
April 22, 2026
Conditions
Keywords
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
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.
Eligibility Criteria
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Boucai, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
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.