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towards individualized therapy for patients with pediatric tumors


- candidate number24401
- NTR NumberNTR5915
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mei-2016
- Secondary IDsNL56826.078.16 CCMO
- Public Titletowards individualized therapy for patients with pediatric tumors
- Scientific TitleTowards Individualized Therapies for Children with Relapsed/Refractory Malignancies using Molecular Profiling
- ACRONYMDCOG-ITHER
- hypothesis
- Healt Condition(s) or Problem(s) studiedPediatric cancer
- Inclusion criteria-relapsed/refractory pediatric cancer, which was established at initial diagnosis by standard diagnostic methods
-no available standard treatment or study protocol
-life-expectancy of at least 10 weeks
-written informed consent according to local law and legislation
-age <30 years
- Exclusion criteria-biopsy considered unsafe
-severe organ toxicity precluding undergoing any of the procedures mentioned in this protocol
-any other condition that may hamper participation according to the treating physician
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2016
- planned closingdate
- Target number of participants150
- Interventionsvenapuncture
- Primary outcomeTo define the number of patients with relapsed/refractory pediatric tumors for whom no standard protocol treatment is available, in whom actionable lesions are identified
- Secondary outcome To determine the number of patients with relapsed/refractory pediatric tumors in the Netherlands each year for whom no standard protocol or treatment is available (per protocol population)
The percentage of patients who are able to undergo a diagnostic tumor biopsy (as standard of care)
The percentage of tumor biopsies associated with procedure-related complications
The percentage of cases in which tumor material was obtained of sufficient quality for molecular profiling
The percentage of cases in which one or more actionable lesions are identified
The percentage of cases in which a mutation in a cancer predisposition gene is identified
The percentage of cases in which the molecular tumor board is able to provide a treatment advice to the treating physician
The time frame between the date of the biopsy and the date of the treatment advice by the molecular tumor board
The percentage of patients treated according to the treatment recommendation
Major side-effects and disease responses observed in the patients treated
Survival parameters (overall and progression-free survival) in the entire cohort of patients with a follow-up duration of 1 year following enrolment.
- Timepointssee protocol
- Trial web sitewww.dcog-ectc.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. C.M. Zwaan
- CONTACT for SCIENTIFIC QUERIESMD. PhD. C.M. Zwaan
- Sponsor/Initiator SKION (DCOG)
- Funding
(Source(s) of Monetary or Material Support)
SKION (DCOG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD27-mei-2016 - 8-jul-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl