Advanced Thyroid Gland Medullary CarcinomaNCT04216732
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
An observational study of Advanced Thyroid Gland Medullary Carcinoma and Stage III Thyroid Gland Medullary Carcinoma AJCC v8, run by M.D. Anderson Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Thyroid Gland Medullary Carcinoma, Stage III Thyroid Gland Medullary Carcinoma AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
- What is being tested?
- Blood Pressure Measurement and Questionnaire Administration
- How many people
- 2,030 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2020to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with MTC including advanced phase MTC determined by clinical team
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Elizabeth G. Grubbs, 713-792-6940, eggrubbs@mdanderson.org
Elizabeth G. Grubbs
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Julie A. Sosa, 415-476-1236
Julie A. Sosa
About this study
Official title: Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- 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
- Being tested
- Blood Pressure Measurement, Questionnaire Administration
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MeasurementOther
Undergo blood pressure measurement
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Pressure Measurement; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
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).
Measured: Up to 4 years
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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start10 Jan 2020
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Thyroid Gland Medullary CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth G Grubbs, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216732
- Sponsor's protocol ID
- 2019-0769
- Other IDs
- NCI-2019-07526, 2019-0769
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management
- ClinicalTrials.gov ID
- NCT04216732
- Acronym / sponsor ID
- 2019-0769
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,030 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire, blood pressure) | – | Other: Blood Pressure Measurement, Other: Questionnaire AdministrationAIM 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with MTC including advanced phase MTC determined by clinical team
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Pressure MeasurementUndergo blood pressure measurement | Other | Observational (questionnaire, blood pressure) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire, blood pressure) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- http://www.mdanderson.orgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth G Grubbs principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Thyroid Gland Medullary Carcinoma and Stage III Thyroid Gland Medullary Carcinoma AJCC v8, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth G Grubbs (713-792-6940, eggrubbs@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of medullary thyroid cancer (MTC) (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.