LeukemiaNCT01016379
Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and bone marrow 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 well patients will respond to treatment. 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, biologic sample preservation procedure and laboratory biomarker analysis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Young Patients With Acute Lymphoblastic Leukemia
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies
- Meets ≥ 1 of the following criteria:
- Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained < 10% leukemic blasts
- ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained > 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)
RATIONALE: Studying samples of blood and bone marrow 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 well patients will respond to treatment.
PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
- To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
- To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
- To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.
OUTLINE: This is a multicenter study.
DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.
Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.
- Conditions
- Leukemia
- Being tested
- DNA analysis, biologic sample preservation procedure, laboratory biomarker analysis
- Keywords
- untreated childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
biologic sample preservation procedureOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of genome-wide genotypes
Mechanism for storing, distributing, and tracking usage of blast and germline genomic information
Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)
Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startNov 2009
- 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 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mignon Loh, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016379
- Sponsor's protocol ID
- AALL08B2
- Other IDs
- COG-AALL08B2, CDR0000659101, NCI-2011-02200
- Status last verified
- May 2016
- First submitted
- 18 Nov 2009
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT01016379
- Acronym / sponsor ID
- AALL08B2
- Conditions
- Leukemia
- Keywords
- untreated childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Nov 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.
RATIONALE: Studying samples of blood and bone marrow 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 well patients will respond to treatment.
PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
- To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
- To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
- To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.
OUTLINE: This is a multicenter study.
DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.
Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young Patients With 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 | – |
| biologic sample preservation procedure | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Determination of genome-wide genotypes
Mechanism for storing, distributing, and tracking usage of blast and germline genomic information
Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)
Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL
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 17 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.
Mignon Loh, MD study chair
University of California, San Francisco
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 17 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?
Determination of genome-wide genotypes. The study lists 4 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 17 May 2016.