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Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216732
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
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.

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 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 the investigator's 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.

After completion of study, patients are followed up every 6 months for up to 3 years.

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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
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022


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
Undergo blood pressure measurement
Other Name: BP

Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Natural history of medullary thyroid cancer (MTC) [ Time Frame: Up to 3 years ]
    The ability to assess for individual patients the likelihood that they will require drug therapy and which therapy is most likely to be effective.

  2. Patients' experience with the different phases of MTC [ Time Frame: Up to 3 years ]
    This information can be integrated into clinical decision-making to define treatment and care options that best reflect the values and preferences of patients, and that are most cost effective.

  3. Association of selected biometric outcomes [ Time Frame: Up to 3 years ]
    Will evaluate the association of dynamic changes in these outcomes with changes or discontinuation of treatment, as well as to better understand the symptom burden related to therapy

  4. Association of selected patient reported outcomes [ Time Frame: Up to 3 years ]
    Will evaluate the association of dynamic changes in these outcomes with changes or discontinuation of treatment, as well as to better understand the symptom burden related to therapy



Information from the National Library of Medicine

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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 or advanced phase (red or gray) MTC determined by clinical team
Criteria

Inclusion Criteria:

  1. Aims 1 and 2: A diagnosis of MTC
  2. Aims 1 and 2: age >/= 18 years
  3. Aims 1 and 2: a registrant in the MTCR. Patients of all disease phases will be eligible for enrollment.
  4. Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team
  5. Aim 3: age >/= 18
  6. Aim 3: a current registrant in the MTC

Exclusion Criteria:

None


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, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Elizabeth G. Grubbs    713-792-6940      
Principal Investigator: Elizabeth G. Grubbs         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Elizabeth G Grubbs M.D. Anderson Cancer Center

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 )
P30CA016672 ( U.S. NIH Grant/Contract )
R01FD006650 ( U.S. FDA Grant/Contract )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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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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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Carcinoma
Carcinoma, Medullary
Thyroid Diseases
Endocrine System Diseases
Adenocarcinoma