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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05733013
Other study ID # 22-320
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 7, 2023
Est. completion date February 7, 2028

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Laura Boucai, MD
Phone 646-608-3906
Email boucail@mskcc.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 7, 2028
Est. primary completion date February 7, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Surveillance Visit
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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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