Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Pressure Measurement, Questionnaire Administration.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
Overview
This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.
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.
Interventions
- Other Blood Pressure Measurement
Undergo blood pressure measurement - Other Questionnaire Administration
Complete questionnaires
Primary outcome measures
- Natural history of medullary thyroid cancer (MTC) [Time frame: Up to 4 years]
- Patients' experience with the different phases of MTC [Time frame: Up to 4 years]
- Association of selected biometric and patient-reported outcomes [Time frame: Up to 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of California San Francisco — San Francisco
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04216732 · 2019-0769 · NCI-2019-07526 · 2019-0769