LeukemiaNCT01245231
Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid 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. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- protein expression analysis, western blotting and flow cytometry
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2010to 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: Diagnosis of acute myeloid leukemia (AML)
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia (AML)
- Cryopreserved AML specimens
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II
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. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
Primary
- To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
- To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
- To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.
Secondary
- To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).
OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.
- Conditions
- Leukemia
- Being tested
- protein expression analysis, western blotting, flow cytometry, laboratory biomarker analysis, medical chart review
- Keywords
- childhood acute myeloid leukemia/other myeloid malignancies
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein expression analysisGenetic
western blottingGenetic
flow cytometryOther
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of constitutive pStat3 with inducible pStat3
Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1
Secondary outcomes (1)
Correlation between pStat3/pStat5 and event-free survival and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startMay 2010
- Primary 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michele S. Redell, MD, PhD, Principal investigator, Texas Children's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245231
- Sponsor's protocol ID
- AAML11B6
- Other IDs
- COG-AAML11B6, CDR0000689410, NCI-2011-02845
- Status last verified
- May 2016
- First submitted
- 19 Nov 2010
- 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
- Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II
- ClinicalTrials.gov ID
- NCT01245231
- Acronym / sponsor ID
- AAML11B6
- Conditions
- Leukemia
- Keywords
- childhood acute myeloid leukemia/other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2010
- Primary completion
- May 2016 (actual)
- First posted
- 22 Nov 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. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
Primary
- To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway activity.
- To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low- and high-doses of cytokines.
- To evaluate the expression levels of Stat3 protein and the upstream and downstream regulators of Stat3 activation.
Secondary
- To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).
OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosis of acute myeloid leukemia (AML)
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 |
|---|---|---|
| protein expression analysis | Genetic | – |
| western blotting | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Correlation of constitutive pStat3 with inducible pStat3
Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1
1 secondary outcome
Correlation between pStat3/pStat5 and event-free survival and overall survival
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.
Michele S. Redell, MD, PhD principal investigator
Texas Children's Cancer Center
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 18 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?
Correlation of constitutive pStat3 with inducible pStat3. 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 18 May 2016.