Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

NCT ID: NCT01510600

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-05-31

Brief Summary

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.

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).

Conditions

Neuroblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

DNA analysis

Intervention Type: GENETIC

polymerase chain reaction

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

medical chart review

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loretta Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Sydney Children's Hospitals Network

Other Identifiers

COG-ANBL12B5

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000722061

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL12B5

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00109

Identifier Type: REGISTRY

Identifier Source: secondary_id

ANBL12B5

Identifier Type: -

Identifier Source: org_study_id