| Conditions: |
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Hypopituitarism - Hypogonadism - Thyroid Dysfunction - Bone Diseases, Metabolic |
| Purpose: |
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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.
...
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| Study Summary: |
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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.
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| Criteria: |
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- 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.
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| NCT ID: |
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NCT00504218 |
| Primary Contact: |
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Principal Investigator
Maya B Lodish, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Maya B Lodish, M.D.
Phone: (301) 496-6683
Email: lodishma@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |