Disseminated NeuroblastomaNCT00898391
Study of DNA in Blood Samples From Patients With Neuroblastoma
An observational study of Disseminated Neuroblastoma and Localized Resectable Neuroblastoma, run by Children's Oncology Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma
- What is being tested?
- laboratory biomarker analysis, polymerase chain reaction and polyacrylamide gel electrophoresis
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with neuroblastoma treated at a COG participating site.
Who may be able to join
- 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
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: Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma
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.
Read the detailed description
OBJECTIVES:
- Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group [COG] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases.
II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System [INSS] stage 1 and 2).
OUTLINE:
Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.
- Conditions
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4S Neuroblastoma
- Being tested
- laboratory biomarker analysis, polymerase chain reaction, polyacrylamide gel electrophoresis, DNA 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
polymerase chain reactionGenetic
Also called PCR
Correlative studies
polyacrylamide gel electrophoresisGenetic
Also called electrophoresis, polyacrylamide gel
Correlative studies
DNA analysisGenetic
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: laboratory biomarker analysis; Genetic: polymerase chain reaction; Genetic: polyacrylamide gel electrophoresis; Genetic: DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR
Measured: Up to 6 months
Limits of the procedure in non-metastatic patients and in those with reduced tumor burden
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2007
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated 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
- Retrospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Hogarty, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898391
- Sponsor's protocol ID
- ANBL07B1
- Other IDs
- NCI-2009-00686, COG-NB2006-10, NB2006-10, ANBL07B1
- Status last verified
- May 2016
- First submitted
- 9 May 2009
- 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
- Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma
- ClinicalTrials.gov ID
- NCT00898391
- Acronym / sponsor ID
- ANBL07B1
- Conditions
- Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4S Neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 2009 (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 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.
Detailed description
OBJECTIVES:
- Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group [COG] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases.
II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System [INSS] stage 1 and 2).
OUTLINE:
Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative | – | Other: laboratory biomarker analysis, Genetic: polymerase chain reaction, Genetic: polyacrylamide gel electrophoresis, Genetic: DNA analysisCirculating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with neuroblastoma treated at a COG participating site.
Key inclusion criteria (3 listed)
- Serum samples from neuroblastoma (NB) patients obtained through the COG (and legacy Children's Cancer Group [CCG]/Pediatric Oncology Group [POG] Biology Studies)
- 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
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 |
| polymerase chain reactionAlso: PCRCorrelative studies | Genetic | Ancillary-Correlative |
| polyacrylamide gel electrophoresisAlso: electrophoresis, polyacrylamide gelCorrelative studies | Genetic | Ancillary-Correlative |
| DNA analysisCorrelative studies | Genetic | Ancillary-Correlative |
Primary outcome
Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR
Time frame: Up to 6 months
Limits of the procedure in non-metastatic patients and in those with reduced tumor burden
Time frame: Up to 6 months
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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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.
Michael Hogarty, 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 Disseminated Neuroblastoma and Localized Resectable 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 3 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?
Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR (time frame: Up to 6 months). The study lists 2 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 18 May 2016.