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Protocol Details

Longitudinal Assessment and Natural History Study of Children and Adults with MEN2A or MEN2B with or without Medullary Thyroid Carcinoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-C-0178

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Mo
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Thyroid Tumor;
Multiple Endocrine Neoplasia 2;
Pheochromocytoma;
RET Mutations;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Medullary Thyroid Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

- Medullary thyroid cancer (MTC) is a rare cancer of the thyroid gland. In children and adults, it is often part of a condition called Multiple Endocrine Neoplasia 2 (MEN2). MEN2 is usually caused by a genetic mutation, and it can cause a number of problems in addition to MTC. These problems include adrenal gland tumors, hormone changes, and problems with the bones and other organs. Not much is known about how MTC develops over time, especially in people with MEN2. Researchers want to study MTC in children and adults and see how it affects their growth and development.

Objectives:

- To study how medullary thyroid cancer affects children and adults over time.

Eligibility:

- Children and adults who have medullary thyroid cancer.

Design:

- Participants will be screened with a brief physical exam and medical history. Blood and tissue samples will be collected to see whether participants have the MEN2 genetic mutation.

- Treatment will not be provided as part of this study. However, participants will be receiving standard care for MTC. They may be eligible for other clinical trials at the National Institutes of Health.

- Participants will have regular study visits every 6 to 12 months to evaluate their MTC and any treatment. Blood tests, imaging studies, and other tests may be performed as needed to monitor the disease.

- Participants and their parents/guardians will also complete questionnaires about their health and emotions during the study.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

John W. Glod, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-3750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6194
john.glod@nih.gov

Nicole Lucas
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 12C432C
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6252
andrea.lucas@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01660984

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