An observational study in Hypopituitarism, Hypogonadism and Thyroid Dysfunction, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Terminated at 1 site in United States. Open to participants aged 2 Years to 24 Years. Per ClinicalTrials.gov, last updated 2018-12-03.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
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:
The following additional studies may be done, as clinically indicated:
Children with endocrine abnormalities are offered standard treatments.
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 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 and/or 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 and/or 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 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.
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.
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's enrollment of 62 is below the median of 137 across 17 observational studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION FOR CAROTID MRI
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Jul 2007 and a completion of Jun 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →