LeukemiaNCT01119586
Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood or 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 1 year to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA analysis, genetic linkage analysis and microarray analysis
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 2015
- 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients With High-Risk Acute Lymphoblastic Leukemia
DISEASE CHARACTERISTICS:
- Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia
- Matched patients non-tumor and blast DNA samples
- Enrolled on COG-P9906 or COG-AALL0232 protocols
- Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri
PATIENT CHARACTERISTICS:
- Newborn infants from the state of Missouri
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
RATIONALE: Studying samples of blood or 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 study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
- To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
- To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
- To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.
OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.
- Conditions
- Leukemia
- Being tested
- DNA analysis, genetic linkage analysis, microarray analysis, nucleic acid sequencing, polymerase chain reaction
- Keywords
- B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
genetic linkage analysisGenetic
microarray analysisGenetic
nucleic acid sequencingGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Prospective
- Enrolment
- 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
- Todd E. Druley, MD, Principal investigator, St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119586
- Sponsor's protocol ID
- AALL10B2
- Other IDs
- COG-AALL10B2, CDR0000672526, NCI-2011-02232
- Status last verified
- Jul 2016
- First submitted
- 6 May 2010
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
- ClinicalTrials.gov ID
- NCT01119586
- Acronym / sponsor ID
- AALL10B2
- Conditions
- Leukemia
- Keywords
- B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 7 May 2010 (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 or 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 study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
- To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
- To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
- To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.
OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients With High-Risk Acute Lymphoblastic Leukemia
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 | – |
| genetic linkage analysis | Genetic | – |
| microarray analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation
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 11 Jul 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.
Todd E. Druley, MD principal investigator
St. Louis Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, 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 11 Jul 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?
Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis. 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 11 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.