Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00504218
First received: July 18, 2007
Last updated: March 14, 2014
Last verified: November 2013
  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

Study Type: Observational
Official Title: Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoitic Stem Cell Transplant Recipients

Resource links provided by NLM:


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 as well as in patients s/p bone marrow transplant throughout their lifespan. 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 and adult patients with endocrine related complications associated with prior cancer therapy and/or hematopoietic stem cell transplant (HSCT) 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 and/or who have received HSCT at the NIH-Clinical center.

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

(iii) The protocol will serve as the basis for outpatient clinics that will function within the context of the pediatric and adult endocrine outpatient clinics: every eligible patient referred to the endocrine service from the NCI, NHLBI, 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 and adults who have been cured of their underlying neoplasms as well as those individuals who are recipients of an HSCT.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Maya B Lodish, M.D. (301) 451-7175 lodishma@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Maya B Lodish, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00504218     History of Changes
Other Study ID Numbers: 070192, 07-CH-0192
Study First Received: July 18, 2007
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Endocrine Side Effects Related to Cancer Therapy
Cancer Therapy Endocrine Side Effects
Childhood Cancer Survivors
Growth Factor
Hypothalamic-Pituitary Dysfunction
Primary Disorders of the Thyroid
Decreased Bone Mineral Density
Primary Gonadal Dysfunction
Obesity
Impaired Glucose Tolerance
Thyroid Disorder
Pituitary Dysfunction

Additional relevant MeSH terms:
Congenital Abnormalities
Bone Diseases
Bone Diseases, Metabolic
Hypogonadism
Hypopituitarism
Metabolic Diseases
Thyroid Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014