Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504218
Status:
TERMINATED
Last Update Posted:
2018-12-03
First Post:
2007-07-18
Brief Title:
Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoietic Stem Cell Transplant Recipients
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoitic Stem Cell Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2018-06-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 sp 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 andor their ligands for growth andor proliferation factors and disruptors of steroid hormone interactions The present study serves as a natural history protocol
As a natural history this protocol allows our Institute to care for pediatric and adult patients with endocrine related complications associated with prior cancer therapy andor hematopoietic stem cell transplant HSCT for the purposes of
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 andor who have received HSCT at the NIH-Clinical center
Developing new clinical studies for the recognition and therapy of endocrine side effects related to cancer therapy andor HSCT this protocol will eventually lead to new separate protocols that will address specific aspects of endocrinopathies in childhood cancer survivors and HSCT survivors
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
As a natural history this protocol allows our Institute to care for pediatric and adult patients with endocrine related complications associated with prior cancer therapy andor hematopoietic stem cell transplant HSCT for the purposes of
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 andor who have received HSCT at the NIH-Clinical center
Developing new clinical studies for the recognition and therapy of endocrine side effects related to cancer therapy andor HSCT this protocol will eventually lead to new separate protocols that will address specific aspects of endocrinopathies in childhood cancer survivors and HSCT survivors
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-CH-0192 | None | None | None |