NeuroblastomaNCT01589341
Studying Chromosomes in Samples From Younger Patients With Neuroblastoma
An observational study of Neuroblastoma, run by Children's Oncology Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- laboratory biomarker analysis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 2012
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Neuroblastoma patient samples
Who may be able to join
- 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%
Show all 11Show fewer
- No DOT
- No patients diagnosed before 1997 and after 2005
- No lack of follow-up data
- See Disease Characteristics
- No initial cytotoxic treatment
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
About this study
Official title: Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
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.
Read the detailed description
OBJECTIVES:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Correlative studies | Archived DNA samples are analyzed (laboratory biomarker analysis) for segmental chromosome aberrations by MLPA, a 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. Receives: Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Estimated by the Kaplan-Meier method.
Measured: From the date of diagnosis to the date of death from any cause, assessed up to 5 years
Secondary outcomes (2)
Event-free survival (EFS)
Estimated by the Kaplan-Meier method.
Measured: From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Ambros, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589341
- Sponsor's protocol ID
- ANBL12B7
- Other IDs
- NCI-2012-01961, CDR0000732465, COG-ANBL12B7
- Status last verified
- May 2016
- First submitted
- 29 Apr 2012
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
- ClinicalTrials.gov ID
- NCT01589341
- Acronym / sponsor ID
- ANBL12B7
- Conditions
- Neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 1 May 2012 (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 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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlative studies | – | Other: laboratory biomarker analysisArchived DNA samples are analyzed (laboratory biomarker analysis) for segmental chromosome aberrations by MLPA, a 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Neuroblastoma patient samples
Key inclusion criteria (11 listed)
- 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
- 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%
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 | Correlative studies |
Primary outcome
Overall survival (OS)
Time frame: From the date of diagnosis to the date of death from any cause, assessed up to 5 years
Estimated by the Kaplan-Meier method.
2 secondary outcomes
Event-free survival (EFS)
Time frame: From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years
Incidence of metastatic relapses using cumulative incidences
Time frame: Up to 5 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 18 May 2016.
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Genomic Structural Variation in Cancer Susceptibility
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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.
Peter Ambros, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
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 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 18 May 2016. 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?
Overall survival (OS) (time frame: From the date of diagnosis to the date of death from any cause, assessed up to 5 years). 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 18 May 2016.