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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

Tracking Information
First Submitted Date November 14, 2019
First Posted Date January 3, 2020
Last Update Posted Date August 31, 2020
Actual Study Start Date January 10, 2020
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2020)
  • 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.
  • 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).
  • 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.
Original Primary Outcome Measures
 (submitted: January 2, 2020)
  • 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.
  • 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.
  • 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
  • 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with MTC including advanced phase MTC determined by clinical team
Condition
  • 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
Intervention
  • Other: Blood Pressure Measurement
    Undergo blood pressure measurement
  • Other: Questionnaire Administration
    Complete questionnaires
Study Groups/Cohorts 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.

Interventions:
  • Other: Blood Pressure Measurement
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 2, 2020)		 2030
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elizabeth G Grubbs 713-792-6940 eggrubbs@mdanderson.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor M.D. Anderson Cancer Center
Original Study Sponsor Same as current
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth G Grubbs M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2020