Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00504218

Purpose

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.

Condition
Hypopituitarism Hypogonadism Thyroid Dysfunction Bone Diseases, Metabolic

MedlinePlus related topics: Bone Diseases Cancer Obesity Obesity in Children

Drug Information available for: Dextrose Thyroid

U.S. FDA Resources

Study Type:	Observational
Official Title:	Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	500
Study Start Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	2 Years to 24 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504218

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

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

Sponsors and Collaborators

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

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	070192, 07-CH-0192
Study First Received:	July 18, 2007
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00504218
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

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

Thyroid Disorder
Cancer Therapy Endocrine Side Effects
Pituitary Dysfunction
Childhood Cancer Survivors

Study placed in the following topic categories:

Hypothalamic Diseases
Obesity
Metabolic Diseases
Pituitary Diseases
Gonadal Disorders
Glucose Intolerance
Central Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Metabolic

Brain Diseases
Bone Diseases
Hypogonadism
Hypopituitarism
Musculoskeletal Diseases
Endocrinopathy
Metabolic disorder
Congenital Abnormalities
Thyroid Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009