Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
N/A
30 Years
Both
Neuroblastoma
Trial Information
Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
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).
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
Safety Issue:
No
Principal Investigator
Loretta Lau, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Hospital at Westmead
Authority:
United States: Federal Government
Study ID:
CDR0000722061
NCT ID:
NCT01510600
Start Date:
January 2012
Completion Date:
Related Keywords:
- Neuroblastoma
- stage 4S neuroblastoma
- localized resectable neuroblastoma
- localized unresectable neuroblastoma
- recurrent neuroblastoma
- regional neuroblastoma
- Neuroblastoma
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