- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00001686
Evaluation, Treatment, and Natural History of Children and Young Adults With Cancer or Rare Diseases
Treatment of Children With Cancer
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
---|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Evaluate children and adults with cancer
Lasso di tempo: End of treatment
|
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
|
End of treatment
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie del sistema immunitario
- Neoplasie, Connettivo e Tessuto Molle
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Neoplasie per sede
- Neoplasie del sistema nervoso centrale
- Neoplasie del sistema nervoso
- Osteosarcoma
- Neoplasie, tessuto osseo
- Neoplasie, tessuto connettivo
- Neoplasie, tessuto muscolare
- Miosarcoma
- Sarcoma
- Linfoma
- Neoplasie cerebrali
- Sarcoma, Ewing
- Rabdomiosarcoma
Altri numeri di identificazione dello studio
- 980037
- 98-C-0037
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .