Evaluation, Treatment, and Natural History of Children With Cancer
Drug: Standard of Care
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Children With Cancer|
- Standard of care [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||December 1997|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
Children are referred to the Pediatric Oncology Branch (POB) for possible enrollment in clinical protocols for the treatment of cancer. While some children are not eligible for a specific protocol, they may present with disease manifestations that offer the potential for important new insights into the pathogenesis or clinical behavior of their underlying disease. In addition, children who have completed participation in a clinical protocol but do not currently have therapeutic protocol alternatives may continue to provide POB with important information. Diseases of interest to the POB include, but are not limited to lymphoma, brain tumors, Ewings sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, and rhabdomyosarcoma. Hence, serial clinical evaluation of such patients, including the performance of clinical, laboratory, and diagnostic studies to help elucidate longitudinally the underlying disease mechanisms, and when clinically indicated standard care therapies, will assist POB meet its overall mission.
To be able to follow and evaluate children with cancer or pre-cancer syndromes referred to the Pediatric Oncology Branch who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific import.
Patients who are evaluated by the Pediatric Oncology Branch and are: Children with cancer (or a pre-cancer syndrome), between the age(s) of 3 months - 40 years who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, because they are likely to shed led light on disease pathogenesis or the clinical behavior of the disorder. Patients between the ages of 30 and 40 years may be evaluated on this protocol if their cancer (or pre-cancer syndrome) is of specific interest to the Pediatric Oncology Branch.
The medical procedures or tests will be selected for each patient on the basis of his/her individual diagnosis (or presumed diagnosis). When clinically indicated, standard therapy will be administered and patients will be followed according to standard medical practice. Specimens may be collected for clinical care purposes only to evaluate the patient s status.
No investigational tests, drugs or therapies will be administered in this protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001686
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Crystal L Mackall, M.D.||National Cancer Institute (NCI)|