Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors

Condition(s) targeted: Hypopituitarism; Hypogonadism; Thyroid Dysfunction; Bone Diseases, Metabolic

Phase: N/A

Status: Recruiting

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Overall contact:
Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

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.

Official title: Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors

Study design: Other

Detailed description: Endocrine dysfunction is increasingly recognized as one of the most important aspects of quality of life issues, physical and psychosocial development and overall prognosis in pediatric patients diagnosed with neoplasms. In addition, several of the new, molecularly designed therapies for neoplasms may interact with endocrine signaling; these include receptors and/or their ligands for growth and/or proliferation factors, and disruptors of steroid hormone interactions. The present study serves as a screening/training protocol.

As a screening and training study, this protocol allows our Institute to care for pediatric patients with endocrine related complications associated with prior cancer therapy for the purposes of:

(i) Training our fellows, residents and students in the identification and management of endocrine abnormalities developing in patients who have been diagnosed with and treated for neoplasms at the NIH-Clinical center.

(ii) Developing new clinical studies for the recognition and therapy of endocrine side effects related to cancer therapy: this protocol will eventually lead to new, separate protocols that will address specific aspects of endocrinopathies in childhood cancer survivors and their therapy.

(iii) The protocol will serve as the basis for an outpatient clinic that will function within the context of the pediatric endocrine outpatient clinic: every eligible patient referred to the pediatric endocrine service from the NCI and other NIH institutions and centers will be enrolled in this study, which for the first time will create an endocrine database for these patients. As stated in our aims above, it is our hope that the present investigation will serve as an incubator of further research-focused studies with the ultimate goal of improving the life of children who have been cured of their underlying neoplasms.

Minimum age: 2 Years. Maximum age: 24 Years. Gender(s): Both.

Criteria:

- INCLUSION CRITERIA:

- Age 2-24 years.

- History of diagnosis of childhood malignancy 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 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.

Patient Recruitment and Public Liaison Office, Phone: (800) 411-1222, Email: prpl@mail.cc.nih.gov

National Institute of Child Health and Human Development (NICHD), 9000 Rockville, Bethesda, Maryland 20892, United States; Recruiting

NIH Clinical Center Detailed Web Page

Related publications:

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.

Starting date: July 2007
Last updated: October 30, 2008