Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01510600
First received: January 11, 2012
Last updated: May 17, 2016
Last verified: May 2016
  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 [ 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
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

Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01510600     History of Changes
Other Study ID Numbers: ANBL12B5  COG-ANBL12B5  CDR0000722061  ANBL12B5  NCI-2012-00109 
Study First Received: January 11, 2012
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 26, 2016