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

NCT00504218 | Terminated

• 2 other identifiers: 07019207-CH-0192
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypopituitarism; Hypogonadism; Thyroid Dysfunction; Bone Diseases, Metabolic

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

Eligibility Criteria

• Age: 2 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

* INCLUSION * Age \>2 years. * History of diagnosis of malignancy or HSCT 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. 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 FOR CAROTID MRI * Metal implants or other ferromagnetic devices, or Foreign material * Claustrophobia

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.3322/canjclin.53.1.5.

  PMID: 12568441 BACKGROUND

• 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. doi: 10.1056/NEJMsa060185.

  PMID: 17035650 BACKGROUND

• Cohen LE. Endocrine late effects of cancer treatment. Endocrinol Metab Clin North Am. 2005 Sep;34(3):769-89, xi. doi: 10.1016/j.ecl.2005.04.008.

  PMID: 16085170 BACKGROUND

MeSH Terms

Conditions

Hypopituitarism; Hypogonadism; Bone Diseases, Metabolic; Obesity; Glucose Intolerance; Thyroid Diseases

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Disorders; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders

Study Officials

• Maya B Lodish, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 19, 2007
• Study Start: July 17, 2007
• Study Completion: June 12, 2018
• Last Updated: December 3, 2018

Record last verified: 2018-06-12

Locations

US (1)