Global Real World Data in Patients With Advanced Thyroid Cancer on Standard of Care and Specialized Interventions- Registry of Oncologic Outcomes With Testing and Treatment.

Recruiting

• Conditions: Thyroid Cancer

• Registration Number: NCT06507878
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for ATC. And to learn about how patients with ATC tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.

Detailed Description

Primary Objectives:

The primary objective of this study is to compare overall survival (OS) between ATC patients treated at MDA versus outside of MDA using treatment regimens offered at MDA based on BRAF status and stage of the disease. We will gather prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status.

Secondary Objectives:

1. To evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for ATC survivors

2. To evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-18
• Study Start: 2024-12-05
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2032-07-01
• Study Completion: 2034-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

All adult patients aged 18 years or older with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included.

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Exclusion Criteria

Patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival	Through study completion; an average of 1 year.	Prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States