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Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

C

Children's Oncology Group

Status

Completed

Conditions

Neuroblastoma

Treatments

Genetic: polymerase chain reaction
Other: medical chart review
Other: laboratory biomarker analysis
Genetic: DNA analysis

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01510600
COG-ANBL12B5 (Other Identifier)
ANBL12B5 (Other Identifier)
NCI-2012-00109 (Registry Identifier)
CDR0000722061 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

99 estimated patients

Sex

All

Ages

Under 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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