- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05733013
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
Conditions
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
- Name: Laura Boucai, MD
- Phone Number: 646-608-3906
- Email: boucail@mskcc.org
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.
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)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-320
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.
Clinical Trials on Thyroid
-
AllerganCompletedHypothyroidism | Thyroid Disease | Euthyroid | Thyroid Gland | Thyroid HormonesUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); University of MichiganCompletedThyroid Cancer | Thyroid Nodule | Benign Thyroid NoduleUnited States
-
Imperial College LondonActive, not recruitingThyroid Cancer | Nodule Solitary ThyroidUnited Kingdom
-
Aarhus University HospitalOdense University Hospital; University of AarhusActive, not recruitingThyroid Cancer | Thyroid Nodule (Diagnosis)Denmark
-
Tseung Kwan O Hospital, Hong KongRecruitingBenign Thyroid Nodule | Suspicious Malignant Thyroid NoduleHong Kong
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
Second Affiliated Hospital of Nanchang UniversitySun Yat-sen University; Beijing Friendship Hospital; Zhejiang University; General... and other collaboratorsActive, not recruitingThyroid | Thyroid Cancer | Thyroid AbnormalitiesChina
-
Sound Blade Medical Inc.Not yet recruitingThyroid Nodules | Thyroid Abnormalities
-
Maria Sklodowska-Curie National Research Institute...CompletedThyroid Cancer | Thyroid Nodule | Thyroid NeoplasmPoland
-
Wuhan UniversityRecruitingThyroid Carcinoma | Thyroid Nodule (Benign) | Ablation; RetinaChina
Clinical Trials on Surveillance Visit
-
University of AlbertaCompleted
-
University of SydneyMelanoma and Skin Cancer Trials LimitedCompleted
-
Intermountain Health Care, Inc.UnknownDeep Vein Thrombosis | Venous Thromboembolism | Trauma, MultipleUnited States
-
The University of Texas Health Science Center at...CompletedBladder CancerUnited States
-
VA Office of Research and DevelopmentNot yet recruitingHigh-Grade Early-Stage Bladder CancerUnited States
-
University Health Network, TorontoActive, not recruiting
-
Umeå UniversityNot yet recruiting
-
Fox Chase Cancer CenterRecruitingCancer | SurgeryUnited States
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...M.D. Anderson Cancer Center; Mayo Clinic; Royal Marsden NHS Foundation Trust; McGill... and other collaboratorsNot yet recruitingSarcoma,Soft Tissue | Sarcoma RetroperitonealUnited Kingdom, Italy
-
Kaiser PermanentePatient-Centered Outcomes Research Institute; University of California, Davis; University of California, San FranciscoCompletedLung Neoplasms | Solitary Pulmonary Nodule | Carcinoma, Non-small-cell Lung | Coin Lesion, PulmonaryUnited States