NCT04216732

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,030

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2020Sep 2026

First Submitted

Initial submission to the registry

November 14, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

6.6 years

First QC Date

November 14, 2019

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

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 MeasurementOther: Questionnaire Administration

Interventions

Undergo blood pressure measurement

Observational (questionnaire, blood pressure)

Complete questionnaires

Observational (questionnaire, blood pressure)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with MTC including advanced phase MTC determined by clinical team

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Elizabeth G Grubbs

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth G Grubbs

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

January 3, 2020

Study Start

January 10, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations