Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma

NCT01510600 | Completed

• 4 other identifiers: ANBL12B5COG-ANBL12B5CDR0000722061NCI-2012-00109
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroblastoma

Keywords

stage 4S neuroblastoma; localized resectable neuroblastoma; localized unresectable neuroblastoma; recurrent neuroblastoma; regional neuroblastoma

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

DNA analysis GENETIC

polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

medical chart review OTHER

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neuroblastoma.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neuroblastoma

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Loretta Lau, MD

  Sydney Children's Hospitals Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 16, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05