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

NCT00504218 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2018-12-03

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Maya B Lodish, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
2 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-17
Completion
2018-06-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504218 on ClinicalTrials.gov