Clinical trial · Observational
Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma
Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
NCT01510600CI-TRIAL-00022309completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
- measure
- Frequency and characteristics of ALT in high-risk NB
- measure
- C-circle level as a marker of ALT activity in NB
- measure
- Prognostic value of ALT
- measure
- C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Snap-frozen neuroblastoma (NB) tumors collected at diagnosis (Objectives 1 to 3)
* High-risk stage 3 or 4 NB AND MYCN non-amplified, i.e., exclude stage 4 infants who are not high-risk
* Up to five high-risk (\> 18 months, unfavorable histology) stage 3/MYCN non-amplified tumors
* Patients preferably treated on protocol COG-A3973 or similar protocols with myeloablative therapy
* At least 3 years of follow-up for those with no event (current evidence suggests that ALT+ NBs often relapse late, i.e., 2 years or longer from diagnosis)
* NB tumor DNA collected at diagnosis (Objectives 2 \& 3)
* High-risk stage 3 or 4 NB as for Objective 1, except for MYCN status
* Stage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of MYCN-amplified and non-amplified tumors
* Frozen serum from NB patients (Objective 5; 2nd stage of project)
* Paired serum obtained at diagnosis from patients with ALT+ or ALT- tumors identified in Objective 2
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.