- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216732
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
Study Overview
Status
Conditions
- Advanced Thyroid Gland Medullary Carcinoma
- Stage III Thyroid Gland Medullary Carcinoma AJCC v8
- Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
- Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8
- Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8
- Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To describe the natural history of medullary thyroid cancer (MTC) using a comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in our existing multi-institutional patient registry.
Ia. To describe the demographic, clinical, pathologic, and genotypic variables associated with each phase of disease.
Ib. To identify those variables which are predictors of progression to the most advanced phases of disease that require small molecule therapy, including commercially approved and experimental agents.
II. To characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
IIa. To describe clinical, psychosocial, economic, and physical well-being variables and the subsequent impact on quality of life associated with each phase of disease.
IIb. To evaluate longitudinal changes in clinical, psychosocial, economic, and physical well-being variables between and within all phases of MTC, and the subsequent impact they have on quality of life.
III. To evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.
OUTLINE:
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.
AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.
The questionnaire data gets paired with the collected medical record history that is maintained in the Registry.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elizabeth G Grubbs
- Phone Number: 713-792-6940
- Email: eggrubbs@mdanderson.org
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco
-
Contact:
- Julie A. Sosa
- Phone Number: 415-476-1236
-
Principal Investigator:
- Julie A. Sosa
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Elizabeth G. Grubbs
- Phone Number: 713-792-6940
- Email: eggrubbs@mdanderson.org
-
Principal Investigator:
- Elizabeth G. Grubbs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aims 1 and 2: A diagnosis of MTC
- Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment
- Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team
- Aim 3: A current registrant in the MTCR
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (questionnaire, blood pressure)
AIM I & II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease. AIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks. |
Complete questionnaires
Undergo blood pressure measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Natural history of medullary thyroid cancer (MTC)
Time Frame: Up to 4 years
|
Will describe the natural history of MTC using comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in existing multi-institutional patient registry.
|
Up to 4 years
|
Patients' experience with the different phases of MTC
Time Frame: Up to 4 years
|
Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
|
Up to 4 years
|
Association of selected biometric and patient-reported outcomes
Time Frame: Up to 4 years
|
Will evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth G Grubbs, 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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma
- Thyroid Diseases
- Thyroid Neoplasms
- Carcinoma, Neuroendocrine
- Carcinoma, Medullary
Other Study ID Numbers
- 2019-0769 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-07526 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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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