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Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510600
First Posted: January 16, 2012
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Alternative Lengthening of Telomeres (ALT) in Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 99
Study Start Date: January 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with neuroblastoma.
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
Information from the National Library of Medicine

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


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01510600     History of Changes
Other Study ID Numbers: ANBL12B5
COG-ANBL12B5 ( Other Identifier: Children's Oncology Group )
CDR0000722061 ( Other Identifier: Clinical Trials.gov )
ANBL12B5 ( Other Identifier: Children's Oncology Group )
NCI-2012-00109 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: January 11, 2012
First Posted: January 16, 2012
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
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