Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589341
• Other study ID #: ANBL12B7
• Secondary ID: NCI-2012-01961CD
• Status: Completed
• Phase: N/A
• First received: April 29, 2012
• Last updated: May 17, 2016
• Start date: April 2012

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This research studies chromosomes in samples from younger patients with neuroblastoma. Studying samples of 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.

Description:

OBJECTIVES:

I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.

OUTLINE:

Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy

• Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome

• DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan

• No MYCN amplification

• No Schwann cell stroma-rich tumors

• No tumor cell content below 60%

• No DOT

• No patients diagnosed before 1997 and after 2005

• No lack of follow-up data

• See Disease Characteristics

• No initial cytotoxic treatment

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Estimated by the Kaplan-Meier method.	From the date of diagnosis to the date of death from any cause, assessed up to 5 years	No
Secondary	Event-free survival (EFS)	Estimated by the Kaplan-Meier method.	From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years	No
Secondary	Incidence of metastatic relapses using cumulative incidences	Grey's test and the model of Fine and Grey will be used for the evaluation of statistical significance.	Up to 5 years	No