- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06507878
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. (GRASSROOT)
Study Overview
Status
Conditions
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:
- To evaluate effect of chemotherapy, immunotherapy, and radiation therapy on the quality of life for ATC survivors
- To evaluate how factors such as health insurance and lack of coverage, adherence, and other sociodemographic characteristics influences patient outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Priyanka C Iyer, MBBS
- Phone Number: (832) 291-6069
- Email: piyer@mdanderson.org
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Priyanka C Iyer, MBBS
- Phone Number: 832-291-6069
- Email: piyer@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All adult patients aged 18 years or older (with the exception of certain external participant countries where the legal adult age may be different; for example in Singapore, adult majors are defined by age 21 and older) with anaplastic thyroid cancer or poorly differentiated thyroid cancer as their clinical and/ or histological diagnosis will be included.
Exclusion Criteria:
Patients who do not have anaplastic thyroid cancer or poorly differentiated thyroid cancer on their tumor tissue would be excluded.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival
Time Frame: 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.
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Priyanka C Iyer, MBBS, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0394
- NCI-2024-06148 (Other Identifier: NIH/NCI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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