Trial Radar IA | ||
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Lo studio clinico NCT07489378 per Very Rare Tumors, Very Rare Cancers, Altri tumori solidi, Tumore solido, Pediatric Rare Tumors è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Istituto nazionale dei tumori, Estados UnidosNCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors 4.000 Pediatrico Adolescenti
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La sperimentazione clinica NCT07489378 è uno studio osservazionale per Very Rare Tumors, Very Rare Cancers, Altri tumori solidi, Tumore solido, Pediatric Rare Tumors, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 5 aprile 2026, con l'obiettivo di raggiungere 4.000 partecipanti. Sotto la guida di l'Istituto nazionale dei tumori, Estados Unidos, dovrebbe concludersi entro il 1 aprile 2037. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 31 marzo 2026.
Sommario breve
Background:
All childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.
Objective:
To gather data for a registry of very rare cancers found in children, teens, and young adults.
Eligibility:...
Mostra di piùDescrizione dettagliata
Background:
- Rare cancers are defined by the NCI as fewer than 15 incident cases per 100,000 people per year. Overall, pediatric tumors account for less than 1% of all cancers diagnosed in the United States (US) per year.
- The European Cooperative Study Group for Pediatric Rare Tumors (EXPeRT) group has determined that the definition of very rare pediatric cancers is fewer than 2 cases per million per year and/or ...
Titolo ufficiale
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Patologie
Very Rare TumorsVery Rare CancersAltri tumori solidiTumore solidoPediatric Rare TumorsAltri ID dello studio
- 10002496
- 002496-C
Numero NCT
Data di inizio (effettiva)
2026-04-05
Ultimo aggiornamento pubblicato
2026-03-31
Data di completamento (stimata)
2037-04-01
Arruolamento (previsto)
4.000
Tipo di studio
Osservazionale
Stato
Non ancora in arruolamento
Parole chiave
Longitudinal Study
Registry
Patient Reported Outcomes
Family History
Molecular Characterization
Registry
Patient Reported Outcomes
Family History
Molecular Characterization
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
1/ Cohort 1 Participants with very rare tumors | Natural history study of individuals with very rare tumors We will collect information about the initial presentation and diagnosis of the disease, management, and tumor treatment history. Participants or parent/guardian will be asked to complete questionnaires and patient-reported outcome (PRO) instruments. Pathology materials (e.g., tissue samples, slides, or blocks) and saliva and/or buccal sample will be requested. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
To establish a longitudinal observational study and registry for very rare pediatric and AYA solid tumors | Percentage of participants from identified recruitment sources will be tabulated and described. An analysis of the ability to adequately obtain medical records at initial evaluation and follow-up to perform medical data extraction, which is critical to establishing a registry and longitudinal observational study will be assessed. | Through 5 years after enrollment |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
To evaluate the feasibility of PRO using validated reporting platforms suitable for pediatric and AYA populations | The percentage of participants who successfully complete longitudinal data collection will be described. | At time of enrollment/study entry, and 2 and 5 years after enrollment |
To conduct comprehensive clinical molecular characterization, utilizing CCDI MCI | The percentage of participants who successfully provide required sample(s) and where correlative analyses are able to be performed will be described. | At time of enrollment/study entry |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
1 Month
Sessi idonei
Tutti
- History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).
- Age >= 1 month and <= 39 years at the time of diagnosis.
- Participants must have established care with a local treating physician.
- Ability of the participant, parent/guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Diagnosis of any of the following at any time:
- Ewing Sarcoma
- Osteosarcoma
- Rhabdomyosarcoma
- Diffuse midline glioma (H3K27 altered)
- Atypical teratoid rhabdoid tumor
- Pleuropulmonary blastoma
- Common adult cancers that occur in pediatric/AYA populations (i.e., colorectal cancer, breast cancer)
The participant is unlikely to comply with the terms of the protocol.
Istituto nazionale dei tumori, Estados UnidosContatti principali dello studio
Contatto: Mary F Wedekind Malone, D.O., (240) 858-3765, [email protected]
1 Centri dello studio in 1 paesi
Maryland
National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States
National Cancer Institute Referral Office, Contatto, 888-624-1937, [email protected]