NeuroblastomaNCT01510600
Studying Biomarkers in Samples From Patients With High-Risk Neuroblastoma
An observational study of Neuroblastoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and 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. PURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- DNA analysis, polymerase chain reaction and laboratory biomarker analysis
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with neuroblastoma.
DISEASE CHARACTERISTICS:
- Snap-frozen neuroblastoma (NB) tumors collected at diagnosis (Objectives 1 to 3)
- High-risk stage 3 or 4 NB AND MYCN non-amplified, i.e., exclude stage 4 infants who are not high-risk
- Up to five high-risk (> 18 months, unfavorable histology) stage 3/MYCN non-amplified tumors
- Patients preferably treated on protocol COG-A3973 or similar protocols with myeloablative therapy
- At least 3 years of follow-up for those with no event (current evidence suggests that ALT+ NBs often relapse late, i.e., 2 years or longer from diagnosis)
- NB tumor DNA collected at diagnosis (Objectives 2 \& 3)
- High-risk stage 3 or 4 NB as for Objective 1, except for MYCN status
- Stage 4 tumors are preferred; may include up to seven high-risk stage 3 tumors with similar distribution of MYCN-amplified and non-amplified tumors
- Frozen serum from NB patients (Objective 5; 2nd stage of project)
- Paired serum obtained at diagnosis from patients with ALT+ or ALT- tumors identified in Objective 2
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
RATIONALE: Studying samples of blood and 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.
PURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma.
Read the detailed description
OBJECTIVES:
- To establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).
- To determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.
- To establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.
- To evaluate the prognostic significance of ALT in NB.
- To evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.
OUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).
- Conditions
- Neuroblastoma
- Being tested
- DNA analysis, polymerase chain reaction, laboratory biomarker analysis, medical chart review
- Keywords
- stage 4S neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
polymerase chain reactionGenetic
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
Frequency and characteristics of ALT in high-risk NB
C-circle level as a marker of ALT activity in NB
Prognostic value of ALT
C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- 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 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Loretta Lau, MD, Principal investigator, Sydney Children's Hospitals Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510600
- Sponsor's protocol ID
- ANBL12B5
- Other IDs
- COG-ANBL12B5, CDR0000722061, ANBL12B5, NCI-2012-00109
- Status last verified
- May 2016
- First submitted
- 11 Jan 2012
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Lengthening of Telomeres (ALT) in Neuroblastoma
- ClinicalTrials.gov ID
- NCT01510600
- Acronym / sponsor ID
- ANBL12B5
- Conditions
- Neuroblastoma
- Keywords
- stage 4S neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, recurrent neuroblastoma, regional neuroblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jan 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.
RATIONALE: Studying samples of blood and 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.
PURPOSE: This research trial studies biomarkers in samples from patients with high-risk neuroblastoma.
Detailed description
OBJECTIVES:
- To establish telomere length measurement by quantitative polymerase chain reaction (qPCR) as an alternative lengthening of telomeres (ALT) detection method in neuroblastoma (NB).
- To determine the frequency of ALT in high-risk NB and the characteristics of ALT+ NB.
- To establish C-circle (extra-chromosomal telomeric DNA circles) level as a marker of ALT activity in NB.
- To evaluate the prognostic significance of ALT in NB.
- To evaluate the utility of the C-circle assay for the detection of circulating tumor DNA in NB patients with an ALT+ tumor.
OUTLINE: Archived tumor tissue and serum samples are analyzed for telomere length measurement, frequency, and C-circle levels by PCR. Results are then compared with patients' age at diagnosis and outcomes including survival data (event-free and overall survival).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with neuroblastoma.
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method
Frequency and characteristics of ALT in high-risk NB
C-circle level as a marker of ALT activity in NB
Prognostic value of ALT
C-circle assay utility in detecting tumor DNA in the serum of NB patients with an ALT
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 19 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.
Loretta Lau, MD principal investigator
Sydney Children's Hospitals Network
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The sensitivity and specificity, as well as the optimal cut-off, for telomere length (TL) qPCR as an ALT detection method. 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 19 May 2016.