Study of DNA in Blood Samples From Patients With Neuroblastoma

NCT00898391 | Completed

• 4 other identifiers: ANBL07B1NCI-2009-00686COG-NB2006-10NB2006-10
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Conditions

Disseminated Neuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma

Outcome Measures

Primary Outcomes (2)

• Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR

  Up to 6 months

• Limits of the procedure in non-metastatic patients and in those with reduced tumor burden

  Up to 6 months

Study Arms (1)

Ancillary-Correlative

Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.

Other: laboratory biomarker analysis; Genetic: polymerase chain reaction; Genetic: polyacrylamide gel electrophoresis; Genetic: DNA analysis

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-Correlative

polymerase chain reaction GENETIC

Correlative studies

Also known as: PCR

Ancillary-Correlative

polyacrylamide gel electrophoresis GENETIC

Correlative studies

Also known as: electrophoresis, polyacrylamide gel

Ancillary-Correlative

DNA analysis GENETIC

Correlative studies

Ancillary-Correlative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with neuroblastoma treated at a COG participating site.

You may qualify if:

• Serum samples from neuroblastoma (NB) patients obtained through the COG (and legacy Children's Cancer Group \[CCG\]/Pediatric Oncology Group \[POG\] Biology Studies)
• The MYCN status on corresponding tumors have been determined using standard techniques; the panel of samples must be obtained from NB patients with and without MYCN amplification tumors
• Cases will be drawn from clinical subsets at greatest likelihood to benefit from this testing ability, stage 1 and 2 NBs (both infants and toddlers), stage 4 patients under 18 months of age, and 4S patients

Sponsors & Collaborators

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

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Polymerase Chain Reaction; Electrophoresis, Polyacrylamide Gel

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; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques

Study Officials

• Michael Hogarty, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: June 1, 2007
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

US (1)