Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
NCT ID: NCT04216732
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2030 participants
OBSERVATIONAL
2020-01-10
2026-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Blood Pressure Measurement
Undergo blood pressure measurement
Questionnaire Administration
Complete questionnaires
Interventions
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Blood Pressure Measurement
Undergo blood pressure measurement
Questionnaire Administration
Complete questionnaires
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elizabeth G Grubbs
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of California San Francisco
San Francisco, California, United States
M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Julie A. Sosa
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Related Links
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http://www.mdanderson.org
Other Identifiers
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NCI-2019-07526
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0769
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0769
Identifier Type: -
Identifier Source: org_study_id
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