Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management

Stage IV Thyroid Gland Medullary Carcinoma AJCC v8 Clinical Trial

Official title:

Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216732
• Other study ID #: 2019-0769
• Secondary ID: NCI-2019-0752620
• Status: Recruiting
• Start date: January 10, 2020
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Elizabeth G Grubbs
• Phone: 713-792-6940
• Email: eggrubbs[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2030
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Thyroid Gland Medullary Carcinoma
• Carcinoma
• Carcinoma, Neuroendocrine
• 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
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Blood Pressure Measurement
Undergo blood pressure measurement
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   http://www.mdanderson.org