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CompletedNCT01510600Updated May 19, 2016

Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

An observational study in Neuroblastoma, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
99
Ages
Up to 30 Years
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

  • To establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).
  • To determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.
  • To establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.
  • To evaluate the prognostic significance of ALT in NB.
  • To evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.

OUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).

02

Conditions studied

  • Neuroblastoma

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Keywords

  • stage 4S neuroblastoma
  • localized resectable neuroblastoma
  • localized unresectable neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
03

In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 99 is below the median of 121 across 77 observational studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with neuroblastoma.

Eligibility criteria

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 Characteristics
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
99 participants (estimated)
Patient registry
No

Interventions

  • GeneticDNA analysis
  • Geneticpolymerase chain reaction
  • Otherlaboratory biomarker analysis
  • Othermedical chart review
06

What researchers measure

Primary outcomes

  1. The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method

  2. Frequency and characteristics of ALT in high-risk NB

  3. C-circle level as a marker of ALT activity in NB

  4. Prognostic value of ALT

  5. C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01510600
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 16, 2012
Start date
Jan 2012
Primary completion
May 2016
Completion
May 2016
Last update
May 19, 2016

Study contacts

Loretta Lau, MD
principal investigator · Sydney Children's Hospitals Network

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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