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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733013
• Other study ID #: 22-320
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Thyroid
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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

External Links

•   Memorial Sloan Kettering Cancer Center