- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001686
Evaluation, Treatment, and Natural History of Children and Young Adults With Cancer or Rare Diseases
Treatment of Children With Cancer
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Background:
Children and adults are referred to the Pediatric Oncology Branch (POB) for possible enrollment in clinical protocols for the treatment of cancer or other rare diseases. 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, Ewing's sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, rhabdomyosarcoma, RAS-related syndromes and inherited immune disorders, amongst others. 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.
Objectives:
To be able to follow and evaluate children and adults with cancer or pre-cancer syndromes and other rare diseases referred to the Pediatric Oncology Branch who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific importance.
Eligibility:
Patients who are evaluated by the Pediatric Oncology Branch and are:
- Children and adults with cancer (or a pre-cancer syndrome or rare disease), with disease manifestations of special interest to Pediatric Oncology Branch investigators.
- Patients must be greater than or equal to 2 years and less than or equal to 40 years of age at the time of study enrollment.
Design:
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
- INCLUSION CRITERIA:
- A POB, CCR investigator decides that it is in the best interest of the patient and the POB, CCR for the patient to receive treatment and follow-up at the NCI/NIH.
- Children and adults with cancer (or a pre-cancer syndrome or a rare disease), between the age (s) of 2 years - 40 years (the NIH CC is not well equipped to provide optimal care to patients < 2 years of age). Note: Patients greater than or equal to 18 and less than or equal to 40 years may be evaluated on this protocol if their cancer (or precancer syndrome or rare disease) is of specific interest to the POB, CCR, NCI.
- Patients with cancer (or a pre-cancer syndrome or rare disease), who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, including but not limited to, lymphoma, brain tumors, Ewing's sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, rhabdomyosarcoma,RAS-related syndromes and inherited immune disorders, amongst others.
- Patient must weigh greater than or equal to 12 kg (the NIH CC is not well equipped to provide optimal care to patients < 12 kg)
- The patient, parent, guardian or their Legally Authorized Representative (LAR) is able and willing to provide informed consent.
- Patients, and when indicated, parent, guardian or LAR who are deemed sufficiently reliable to return for recommended follow-up visits.
EXCLUSION CRITERIA:
- Patients younger than 2 years of age.
- Patients weighing less than or equal to 12 kg.
- Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform these may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no invasive clinical or research procedures will be done or cancer treatment provided during pregnancy that include unacceptable risk to the patient and/or to the unborn fetus.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Cohort A
Children and adults with cancer (or a pre-cancer syndrome or rare disease), between the age(s) of 2 years - 40 years, who present with disease manifestations of special interest to POB investigators.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluate children and adults with cancer
Periodo de tiempo: End of treatment
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evaluate longitudinally children and adults with cancer, pre-canceroussyndromes or rare diseases referred to the Pediatric Oncology Branch (POB) who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific importance
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End of treatment
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Neoplasias por sitio
- Neoplasias del Sistema Nervioso Central
- Neoplasias del Sistema Nervioso
- Osteosarcoma
- Neoplasias De Tejido Óseo
- Neoplasias Del Tejido Conectivo
- Neoplasias De Tejido Muscular
- Miosarcoma
- Sarcoma
- Linfoma
- Neoplasias Cerebrales
- Sarcoma de Ewing
- Rabdomiosarcoma
Otros números de identificación del estudio
- 980037
- 98-C-0037
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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