LeukemiaNCT01626183
Studying RNA in Samples From Younger Patients With T-Cell Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer PURPOSE: This laboratory study is looking into RNA in samples from younger patients with T-cell (T) acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- RNA analysis, proteomic profiling and laboratory biomarker analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: pediatric patients with diagnosed or relapsed T-ALL
DISEASE CHARACTERISTICS:
- Peripheral blood and bone marrow samples from pediatric patients with diagnosed and relapsed T-ALL
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Molecular Taxonomy in Pediatric Cancer- IncRNA Expression in Primary T-ALL
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
PURPOSE: This laboratory study is looking into RNA in samples from younger patients with T-cell (T) acute lymphoblastic leukemia (ALL).
Read the detailed description
OBJECTIVES:
- Characterization of the transcriptomic landscape in diagnosis and relapse of T-cell acute lymphoblastic leukemia (ALL) and the direct comparison with corresponding physiological samples (human thymus).
- Perform high-throughput transcriptome ribonucleic acid (RNA) sequencing using matched diagnostic T-precursor pediatric ALL samples (peripheral blood or bone marrow).
OUTLINE: Archived peripheral blood and bone marrow samples are analyzed for long non-coding RNA (IncRNA) expression and sequencing.
- Conditions
- Leukemia
- Being tested
- RNA analysis, proteomic profiling, laboratory biomarker analysis
- Keywords
- T-cell 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.
RNA analysisGenetic
proteomic profilingGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of IncRNA of pediatric T-cell acute lymphoblastic leukemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startMay 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 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Iannis Aifantis, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626183
- Sponsor's protocol ID
- AALL12B8
- Other IDs
- COG-AALL12B8, CDR0000735509, NCI-2012-01980
- Status last verified
- May 2016
- First submitted
- 20 Jun 2012
- 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
- Molecular Taxonomy in Pediatric Cancer- IncRNA Expression in Primary T-ALL
- ClinicalTrials.gov ID
- NCT01626183
- Acronym / sponsor ID
- AALL12B8
- Conditions
- Leukemia
- Keywords
- T-cell childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Jun 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 tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
PURPOSE: This laboratory study is looking into RNA in samples from younger patients with T-cell (T) acute lymphoblastic leukemia (ALL).
Detailed description
OBJECTIVES:
- Characterization of the transcriptomic landscape in diagnosis and relapse of T-cell acute lymphoblastic leukemia (ALL) and the direct comparison with corresponding physiological samples (human thymus).
- Perform high-throughput transcriptome ribonucleic acid (RNA) sequencing using matched diagnostic T-precursor pediatric ALL samples (peripheral blood or bone marrow).
OUTLINE: Archived peripheral blood and bone marrow samples are analyzed for long non-coding RNA (IncRNA) expression and sequencing.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pediatric patients with diagnosed or relapsed T-ALL
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 |
|---|---|---|
| RNA analysis | Genetic | – |
| proteomic profiling | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Identification and characterization of IncRNA of pediatric T-cell acute lymphoblastic leukemia
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.
Iannis Aifantis, PhD principal investigator
NYU Langone Health
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.
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?
Identification and characterization of IncRNA of pediatric T-cell acute lymphoblastic leukemia. 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.