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Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

Alternative Lengthening of Telomeres (ALT) in Neuroblastoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01510600
Enrollment
99
Registered
2012-01-16
Start date
2012-01-31
Completion date
2016-05-31
Last updated
2016-05-19

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

Conditions

Neuroblastoma

Keywords

stage 4S neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma

Brief 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.

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).

Interventions

GENETICDNA analysis
GENETICpolymerase chain reaction
OTHERlaboratory biomarker analysis
OTHERmedical chart review

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
Frequency and characteristics of ALT in high-risk NB
C-circle level as a marker of ALT activity in NB
Prognostic value of ALT
C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026