Observing the progression of medullary thyroid cancer in children and adults
Longitudinal Assessment and Natural History Study of Children and Adults With MEN2A or MEN2B With or Without Medullary Thyroid Carcinoma
This study is looking at how medullary thyroid cancer affects children and adults, especially those with a genetic condition called MEN2, to better understand how the disease progresses over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 259 (estimated) |
| Ages | 4 Months and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01660984 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the natural history of medullary thyroid cancer (MTC) in both children and adults, particularly in those with Multiple Endocrine Neoplasia 2 (MEN2). Participants will undergo a brief physical examination and provide blood and tissue samples to assess for the MEN2 genetic mutation. The study will not provide treatment but will focus on how MTC affects growth and development over time. By gathering this data, researchers hope to gain insights into the disease's progression and its impact on patients.
Who should consider this trial
Good fit: Ideal candidates include children and adults diagnosed with medullary thyroid cancer or confirmed MEN2A or MEN2B.
Not a fit: Patients who do not have medullary thyroid cancer or MEN2-related conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of medullary thyroid cancer, leading to improved management and treatment strategies for affected patients.
How similar studies have performed: While there have been studies on MTC, this specific observational approach focusing on the natural history in the context of MEN2 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA FOR PATIENTS: * Patients must have histologically or cytologically confirmed MTC, confirmed by the Laboratory of Pathology, NCI OR Confirmation of MEN2A or MEN2B diagnosis, regardless of presence of MTC. * Performance Status: Ability to travel to the NIH and to undergo evaluations to be performed on this protocol. * Informed Consent: Ability of patient or their legal guardian (if the patient is \<18 years old) to understand and willing to sign a written informed consent document. * Prior and current therapy: For the purpose of this study subjects who have not previously received medical or surgical treatment, patients, who have previously received medical or surgical treatment, and subjects who are currently receiving medical treatment and/or radiation for MEN 2 related manifestation(s) will be eligible. Prior and current treatment for MEN 2 related manifestations will be recorded at trial entry and throughout the study. * Patients must have a primary care provider (for example a primary oncologist or endocrinologist) who can provide and coordinate the medical care for the patient. EXCLUSION CRITERIA FOR PATIENTS: -In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies. Inclusion Criteria for Parents or Primary Caregivers * Must be a parent or primary caregiver of a patient (\< 21) who has a histologically or cytologically confirmed MTC or who have MEN2 (regardless of MTC status). * Ability to understand and be willing to sign a written informed consent document. EXCLUSION CRITERIA FOR PARENTS OR PRIMARY CAREGIVERS: None
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: John W Glod, M.D. — National Cancer Institute (NCI)
- Study coordinator: Andrea N Lucas
- Email: andrea.lucas@nih.gov
- Phone: (240) 760-6252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.