Localized Resectable NeuroblastomaNCT00436696
Genetic Analysis Using Blood or Bone Marrow From Participants With Neuroblastoma or Noncancerous Conditions
An observational study of Localized Resectable Neuroblastoma and Localized Unresectable Neuroblastoma, run by Children's Oncology Group at 2 sites in United States.
Trial summary
This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 9,350 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Dec 2006to 5 May 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient:
- Diagnosis of neuroblastoma
- Banked constitutional and genomic DNA within COG-ANBL00B1 Neuroblastoma Biology protocol or another COG Biology Protocol
- At least 1.0 ?g of DNA available
- Control (age, race, and gender-matched):
- No diagnosis of cancer
Show all 11Show fewer
- May have other conditions, including any of the following:
- Asthma
- Inflammatory bowel disease
- Attention-deficit disorder
- Obesity
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104
About this study
Official title: Genetic Basis of Neuroblastoma Tumorigenesis
This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma.
Read the detailed description
OBJECTIVES:
- Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.
II. Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.
III. Validate disease-associated SNP alleles and haplotypes in a final independent sample set.
IV. Identify neuroblastoma predisposition genes.
OUTLINE: This is a multicenter study. Participants are stratified according to presence of high-risk disease (yes vs no) and MYCN amplification (yes vs no).
DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.
Patients do not receive the results of the genetic testing. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the Children's Oncology Group.
- Conditions
- Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 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 group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (SNP analysis) | DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroblastoma predisposition genes
Measured: Up to 4 years
Single nucleotide polymorphism (SNP) allele disease association
Measured: Up to 4 years
SNP haplotype disease association
Measured: Up to 4 years
Validation of SNP allele and haplotype disease association
Measured: Up to 4 years
SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study start11 Dec 2006
- Primary completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Resectable NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Maris, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436696
- Sponsor's protocol ID
- ANBL06B1
- Other IDs
- NCI-2009-00403, CDR0000522985, COG-ANBL06B1, ANBL06B1, ANBL06B1, ANBL06B1
- Status last verified
- Oct 2017
- First submitted
- 15 Feb 2007
- Last updated
- 7 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Neuroblastoma Tumorigenesis
- ClinicalTrials.gov ID
- NCT00436696
- Acronym / sponsor ID
- ANBL06B1
- Conditions
- Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,350 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Dec 2006 (actual)
- Primary completion
- 5 May 2016 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This laboratory study is looking at genes in participants with neuroblastoma or noncancerous conditions. Identifying genes related to cancer may help in the study of cancer. It may also help doctors predict who is at risk of developing neuroblastoma.
Detailed description
OBJECTIVES:
- Perform a whole genome scan for association of neuroblastoma with single nucleotide polymorphisms (SNP) and SNP haplotypes.
II. Identify true disease-associated SNP alleles using a customized genotyping platform enriched for haplotype analyses in an independent sample set.
III. Validate disease-associated SNP alleles and haplotypes in a final independent sample set.
IV. Identify neuroblastoma predisposition genes.
OUTLINE: This is a multicenter study. Participants are stratified according to presence of high-risk disease (yes vs no) and MYCN amplification (yes vs no).
DNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition.
Patients do not receive the results of the genetic testing. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the Children's Oncology Group.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (SNP analysis) | – | Other: Laboratory Biomarker AnalysisDNA samples are derived from participants' banked blood or uninvolved bone marrow. A whole genome scan of DNA samples is employed to identify candidate single nucleotide polymorphisms (SNPs). The candidate SNPs are investigated, using a gene-centric haplotyping approach, to identify 10-20 true disease-associated alleles. The disease-associated alleles are again investigated, using a gene-centric haplotyping approach, to validate 5-10 disease-associated SNPs. SNPs are then analyzed for heritable predisposition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patient:
- Control (age, race, and gender-matched):
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-correlative (SNP analysis) |
Primary outcome
Neuroblastoma predisposition genes
Time frame: Up to 4 years
Single nucleotide polymorphism (SNP) allele disease association
Time frame: Up to 4 years
SNP haplotype disease association
Time frame: Up to 4 years
Validation of SNP allele and haplotype disease association
Time frame: Up to 4 years
SNP association with phenotypic subsets (i.e., high-risk vs no high-risk disease; MYCN amplification vs no MYCN amplification)
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Localized Resectable Neuroblastoma
Active, not recruitingPhase 3
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
Ganglioneuroblastoma, Localized Resectable Neuroblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Maris principal investigator
Children's Oncology Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Localized Resectable Neuroblastoma and Localized Unresectable Neuroblastoma, run by Children's Oncology Group at 2 sites 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 11 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Neuroblastoma predisposition genes (time frame: Up to 4 years). The study lists 5 primary outcomes in all. 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 7 Aug 2018.