Protocol Details

Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoitic Stem Cell Transplant Recipients

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	07-CH-0192
Sponsoring Institute	National Institute of Child Health and Human Development (NICHD)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 2 Max Age: 24
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Growth Factor; Hypothalamic-Pituitary Dysfunction; Primary Disorders of the Thyroid; Decreased Bone Mineral Density; Endocrine Side Effects Related to Cancer Therapy; Primary Gonadal Dysfunction; Obesity; Impaired Glucose Tolerance
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

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 24 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.

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Eligibility

INCLUSION CRITERIA:

-Age greater than or equal to 2 years.

-History of diagnosis of childhood malignancy or HSCT and completion of therapy prior to entering the study. In order to be eligible for the study, patients must have been diagnosed with cancer prior to the age of 18. 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 questionnaire. This instrument has been validated for use in children ages five and older. Children 10 years and older will complete the child version. The Child Health Questionnaire (CHQ) has been normed in a representative sample in the US, and is being used in large population studies in Australia, Ireland, and the UK. Additionally, it has been rigorously translated into a number of languages using international guidelines including American-Spanish, Canadian French, Dutch, Finnish, French, German, Italian, Greek, Honduran- Spanish, Mexican-Spanish, Norwegian, Portuguese, and Swedish. For this study will purchase the CHQ in American- Spanish in order to include Spanish-speaking subjects in this part of the study. The costs to purchase the CHQ in numerous languages would be prohibitive for this pilot study. However, if a significant number of subjects in a specific language are recruited, we will consider the purchase of the CHQ for that group of subjects.

EXCLUSION CRITERIA:

-None besides not meeting the inclusion.

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Citations:

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.

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Maya B. Lodish, M.D. National Institute of Child Health and Human Development (NICHD) National Institutes of Health Building 9 Room 1E126 9 Center Drive Bethesda, Maryland 20892 (301) 435-1946 bonner@helix.nih.gov	Maya B. Lodish, M.D. National Institute of Child Health and Human Development (NICHD) National Institutes of Health Building 9 Room 1E126 9 Center Drive Bethesda, Maryland 20892 (301) 435-1946 bonner@helix.nih.gov	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 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00504218

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