Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma
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.
Genetic: DNA analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: medical chart review
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Alternative Lengthening of Telomeres (ALT) in Neuroblastoma|
- The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method [ Designated as safety issue: No ]
- Frequency and characteristics of ALT in high-risk NB [ Designated as safety issue: No ]
- C-circle level as a marker of ALT activity in NB [ Designated as safety issue: No ]
- Prognostic value of ALT [ Designated as safety issue: No ]
- C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510600
|Principal Investigator:||Loretta Lau, MD||Children's Hospital at Westmead|