Fracture Risk in Pediatric Patients With MEN2B.
Iris Li, Iris R Hartley, Joanna Klubo-Gwiedzdzinska...
https://pubmed.ncbi.nlm.nih.gov/36056624Actively Recruiting
Age: 4Months +
All Genders
Healthy Volunteers
ID01660984
Longitudinal Assessment and Natural History Study of Children and Adults With MEN2A or MEN2B With or Without Medullary Thyroid Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-06-08
259
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Medullary thyroid cancer (MTC) is a rare tumor of the thyroid gland often linked with a genetic condition called Multiple Endocrine Neoplasia 2 (MEN2), which affects children and adults. MEN2 can cause other health issues such as adrenal gland tumors and bone problems. Researchers aim to better understand how MTC and MEN2 develop and affect patients over time, particularly focusing on the biology and non-tumor symptoms associated with these conditions. This observational study involves children and adults diagnosed with MTC or MEN2, including those with or without MTC symptoms. Participants will undergo regular evaluations every 6 to 12 months, involving physical exams, medical history reviews, blood and tissue sample collection, and imaging studies. No investigational treatments are given as part of this study; instead, participants continue their standard medical care and may join other clinical trials if eligible. Throughout the study, participants and their caregivers will complete questionnaires about health and emotional well-being. Researchers will analyze tumor growth rates and molecular changes in cancer cells over five years. The study also monitors non-tumor manifestations of MEN2 and collects comprehensive clinical and molecular data. This ongoing monitoring helps improve understanding of the disease and its impact on growth and development in patients.
CONDITIONS
Brief Title
Natural History Study of Children and Adults With Medullary Thyroid Cancer
Who Can Participate
Age: 4Months +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed medullary thyroid cancer or a confirmed diagnosis of MEN2A or MEN2B, regardless of MTC status.
- Ability to travel to the NIH and undergo required evaluations.
- Ability of patient or legal guardian to understand and sign informed consent.
- Patients may be untreated, previously treated, or currently receiving treatment for MEN2-related conditions.
- Patients must have a primary care provider who can coordinate their medical care.
- Parents or primary caregivers of patients under 21 with confirmed MTC or MEN2 must be able to understand and sign informed consent.
You will not qualify if you...
- Patients unable to return for follow-up visits or obtain required studies as judged by the investigator.
- No exclusion criteria for parents or primary caregivers.
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 5 years
Participants undergo clinical and radiological evaluations to assess medullary thyroid carcinoma and manifestations of MEN2 over time.
Periodic visits as scheduled by the study team
Sample Collection
Duration - Up to 5 years
Detailed pathologic and molecular analysis of tumor specimens and biological samples will be performed to study molecular pathways involved in MTC.
Visits for sample collection as needed
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
A
Andrea N Lucas
J
John W Glod, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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