Clinical trial NCT04216732: Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
Official title: Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-03
Enrollment: 2030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with MTC including advanced phase MTC determined by clinical team

Brief summary: 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.

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

Primary outcomes:
measure: Natural history of medullary thyroid cancer (MTC)
timeFrame: Up to 4 years
measure: Patients' experience with the different phases of MTC
timeFrame: Up to 4 years
measure: Association of selected biometric and patient-reported outcomes
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elizabeth G Grubbs
role: PRINCIPAL_INVESTIGATOR
References: