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Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01510600
First received: January 11, 2012
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Study Type: Observational
Official Title: Alternative Lengthening of Telomeres (ALT) in Neuroblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 99
Study Start Date: January 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed 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).

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510600

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Loretta Lau, MD Children's Hospital at Westmead
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01510600     History of Changes
Other Study ID Numbers: CDR0000722061, COG-ANBL12B5
Study First Received: January 11, 2012
Last Updated: January 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage 4S neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013