Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT01510600|
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : May 19, 2016
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.
|Condition or disease||Intervention/treatment|
|Neuroblastoma||Genetic: DNA analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: medical chart review|
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||99 participants|
|Official Title:||Alternative Lengthening of Telomeres (ALT) in Neuroblastoma|
|Study Start Date :||January 2012|
|Primary Completion Date :||May 2016|
|Study Completion Date :||May 2016|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510600
|Principal Investigator:||Loretta Lau, MD||Sydney Children's Hospitals Network|