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Minimal residual disease (MRD) monitoring in neuroblastoma to improve MRD based risk stratification

Minimal residual disease (MRD) monitoring in neuroblastoma to improve MRD based risk stratification - MRD monitoring in children with neuroblastoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30826
Enrollment
60
Registered
2008-01-14
Start date
2008-01-18
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroblastoma small round blue cell tumor

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - children with high or medium risk neuroblastoma - treated according to dutch-german protocol

Exclusion criteria

Exclusion criteria: - children with low risk neuroblastoma - children with ganglioneuroma

Design outcomes

Primary

MeasureTime frame
1. Determination of the value in high-risk neuroblastoma using RQ-PCR to test the presence of PHOX2b, TH, DDC, DBH, GAP43 and CHRNA3. The BM samples will be scored positive, negative or inconclusive and this outcome will be compared to the conventional testing. The MRD status will be monitored at different time points during treatment in BM and PB. The RQ-PCR data will be correlated to survival data. Primary outcomes will be overall durvival (death) and event free survival (relapse) 2. Paired BM and PB samples will be tested, scored (positive, negative and inconclusive) and compared. This study will evaluate the effectiveness of determining MRD in PB samples.

Secondary

MeasureTime frame
1. A secondary outcome is the clinical significance of MRD positive BM or PB samples (using RQ-PCR) in non-high risk neuroblastoma patients. The BM or PB samples will be scored positive, negative and inconclusive and this outcome will be correlated to the event free or overall survival. 2. Furthermore we will use RQ-PCR testing with our set of markers to monitor the MRD status after completing therapy. The PB samples will be scored positive, negative or inconclusive and outcome will be correlated to the event free or overall survival.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)