Protocol Number: 07-CH-0192

Title:

Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors

Number:

07-CH-0192

Summary:

This study will determine the prevalence of endocrine-related side effects in children who have been treated for cancer and establish a database and registry organized according to cancer diagnosis, treatments and endocrine side effects. In children, the endocrine system, which includes glands and hormones that help to control metabolism, growth, development and reproduction, is particularly vulnerable to long-term side effects associated with cancer and its treatments. The study will also serve to help train medical fellows, residents and students in identifying and managing endocrine abnormalities in children who have been diagnosed with and treated for cancer.

Children between 2 and 18 years of age who have been treated for a childhood cancer and have been disease-free for at least 1 year may be eligible for this study.

All participants undergo the following procedures:

-Review of cancer treatment record

-Review of medical and family history

-Blood draw for DNA studies

-Physical examination and body measurements (height, weight, waist, body proportions)

-Completion of child health questionnaires

-Individualized screening and counseling program

-Review of the following endocrine systems: growth, pituitary and hypothalamic function, thyroid function, ovary and testicular function, bone health, risk of obesity and diabetes

The following additional studies may be done, as clinically indicated:

-Magnetic resonance imaging (MRI) of the brain

-Thyroid, testicular or ovarian ultrasound

-DEXA scan to measure bone density

-Wrist x-ray to measure bone age

-Blood tests

-Urine pregnancy test for girls who are old enough to have menstrual periods

-Stimulation testing (tests that involve giving medicine by mouth or in the vein and then measuring blood levels of substances afterwards, such as oral glucose tolerance test, arginine-clonidine growth hormone stimulation test, ACTH stimulation test, and gonadotropin-releasing hormone stimulation test)

Children with endocrine abnormalities are offered standard treatments.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

-Age 2-18 years.

-History of diagnosis of childhood malignancy and completion of therapy prior to entering the study. Eligible patients must be free of their underlying malignancy for at least one year prior to entering the study, as confirmed by records from the referring oncologist.

-We will request permission to administer the Child Health Questionnaires (PF 50 and CF87) to all patients who are enrolled in this protocol. Patients who do not speak and read English will be excluded from the questionaire. this instrument has been validated for use in children ages five and older. Children 10 years and older will complete the child version.

EXCLUSION CRITERIA:

-None besides not meeting the inclusion.

Special Instructions:

Currently Not Provided

Keywords:

Growth Factor

Hypothalamic-Pituitary dysfunction

Primary Disorders of the Thyroid, Primary Gonadal Dysfunction

Decreased Bone Mineral Density, Obesity, Impaired Glucose Tolerance

Endocrine side effects related to cancer therapy

Recruitment Keyword(s):

Thyroid Disorder

Cancer Therapy Endocrine Side Effects

Pituitary Dysfunction

Childhood Cancer Survivors

Condition(s):

Hypopituitarism

Hypogonadism

Thyroid Dysfunction

Bone Diseases, Metabolic

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ.Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.

Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82.

Cohen LE.Endocrine late effects of cancer treatment. Endocrinol Metab Clin North Am. 2005 Sep;34(3):769-89, xi. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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