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

Completed

• Conditions: neuroblastoma; small round blue cell tumor; 10029211

• Registration Number: NL-OMON30826
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

- children with low risk neuroblastoma
- children with ganglioneuroma

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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