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Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management

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ClinicalTrials.gov Identifier: NCT04216732
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
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 Other: Blood Pressure Measurement Other: Questionnaire Administration

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 Design
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Study Type : Observational
Estimated Enrollment : 2030 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.

 Other: Blood Pressure Measurement
Undergo blood pressure measurement

Other: Questionnaire Administration
Complete questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. Natural history of medullary thyroid cancer (MTC) [ Time Frame: 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.

  2. Patients' experience with the different phases of MTC [ Time Frame: Up to 4 years ]
    Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).

  3. Association of selected biometric and patient-reported outcomes [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with MTC including advanced phase MTC determined by clinical team
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216732


Contacts
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Contact: Elizabeth G Grubbs 713-792-6940 eggrubbs@mdanderson.org

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Julie A. Sosa    415-476-1236      
Principal Investigator: Julie A. Sosa         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth G. Grubbs    713-792-6940    eggrubbs@mdanderson.org   
Principal Investigator: Elizabeth G. Grubbs         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elizabeth G Grubbs M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04216732    
Other Study ID Numbers: 2019-0769
NCI-2019-07526 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0769 ( Other Identifier: M D Anderson Cancer Center )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Medullary
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
 Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms