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NeuroblastomaNCT00907920

Studying Tumor Samples From Young Patients With Neuroblastoma

An observational study of Neuroblastoma, run by Children's Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is looking at tumor samples from young 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 Read more about this study

Who is it for?
Ages Up to 30 years
Conditions the study is for
Neuroblastoma
What is being tested?
laboratory biomarker analysis
How many people
1,500 participants
Where
1 siteUnited States
Study dates
Dec 2008to Dec 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients with newly diagnosed neuroblastoma previously enrolled on clinical trial COG-ANBL00B1.

Who may be able to join

  • Tumor DNA samples available from pediatric patients with newly diagnosed neuroblastoma previously enrolled on clinical trial COG-ANBL00B1

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Oncology Group

    Monrovia, California, 91006-3776

Other trials in United States

About this study

Official title: Observational - Characterizing the Frequency and Spectrum of ALK Mutations in Neuroblastoma

This research study is looking at tumor samples from young 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

Read the detailed description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients previously enrolled on clinical trial COG-ANBL00B1 Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVE:

  1. To comprehensively identify and characterize the spectrum and frequency of mutations in ALK across all neuroblastoma disease subsets using methodologies that will be resource neutral to the Children's Oncology Group Neuroblastoma Nucleic Acids Bank.

SECONDARY OBJECTIVES:

  1. To formulate genetic screening recommendations for newly diagnosed patients with or without a family history of neuroblastoma.

II. To identify the functionally relevant ALK mutations that can be pharmacologically inhibited.

III. To test for the prognostic capability of ALK alterations. IV. To determine the clinical significance of ALK mutations and/or genomic rearrangements by combining ALK mutation, amplification, and translocation data overall and within each neuroblastoma risk group and correlating this information with clinical phenotype (i.e., age, International Neuroblastoma Staging System stage, and International Neuroblastoma Pathology Classification); genetic factors (i.e., ploidy, MYCN status); and patient outcome.

OUTLINE:

Tumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for single nucleotide polymorphisms (SNPs) by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy).

A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel.

Conditions
Neuroblastoma
Being tested
laboratory biomarker analysis
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00907920
Study groupRoleWhat they receive
Correlative studiesTumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for SNPs by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy). A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel.
Receives: Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    Using the log rank test, univariate comparisons of EFS and overall survival (OS) will be made for patients with ALK mutations versus those without ALK mutations.

    Measured: Up to 1 year

Secondary outcomes (2)
  1. Overall survival

    Using the log rank test, univariate comparisons of EFS and OS will be made for patients with ALK mutations versus those without ALK mutations.

    Measured: Up to 1 year

  2. Disease progression as assessed by International Neuroblastoma Response Criteria

    Measured: From the time of diagnosis until the time of first occurrence of relapse, progression, secondary malignancy, or death, or until the time of last contact if no event occurred, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907920
Sponsor's protocol ID
ANBL09B1
Other IDs
NCI-2009-00501, NB 2008-08
Status last verified
May 2015
First submitted
22 May 2009
Last updated
13 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuroblastoma, run by Children's Oncology Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.

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