Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management

Recruiting

• Conditions: Stage III Thyroid Gland Medullary Carcinoma AJCC v8; Stage IV Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8; Advanced Thyroid Gland Medullary Carcinoma; Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
• Interventions: Other: Blood Pressure Measurement; Other: Questionnaire Administration

• Registration Number: NCT04216732
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Study Start: 2020-01-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2030

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, blood pressure)	Questionnaire Administration	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.
Observational (questionnaire, blood pressure)	Blood Pressure Measurement	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.

Primary Outcome Measures

Name	Time	Method
Patients' experience with the different phases of MTC	Up to 4 years	Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).
Natural history of medullary thyroid cancer (MTC)	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.
Association of selected biometric and patient-reported outcomes	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.

Trial Locations

Locations (2)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States