NCT Number: NCT01510600
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.
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Conditions
Age range
Up to 30 year
Sex eligibility
All sexes
Study type
Observational
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
polymerase chain reaction
Geneticlaboratory biomarker analysis
Othermedical chart review
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Children's Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
Important dates
- Study start
- 2012
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 16, 2012
- Registry last updated
- May 19, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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