LeukemiaNCT01232855
Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- protein expression analysis, western blotting and flow cytometry
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 2011
- 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 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Acute Promyelocytic Leukemia
DISEASE CHARACTERISTICS:
- Diagnosis of acute promyelocytic leukemia
- Available cryopreserved cells from diagnosis or cryopreserved cells from remission (germline)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Regulation of S100A10 by the PML-RAR-alpha Oncoprotein
RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia.
Read the detailed description
OBJECTIVES:
- Demonstrate that S100A10 is expressed on APL cells and that levels of S100A10 correspond to the amount of fibrinolytic activity.
- Evaluate the impact of ATRA on S100A10 level and fibrinolytic activity in vitro.
- Evaluate the impact of S100A10 knockdown on fibrinolytic activity.
- Correlate in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy.
OUTLINE: This is a multicenter study.
Previously collected samples are analyzed via flow cytometry and western blot analysis. Cell surface levels of S100A10 and annexin A2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin A2 and S100A10 in acute promyelocytic leukemia cells.
- Conditions
- Leukemia
- Being tested
- protein expression analysis, western blotting, flow cytometry, laboratory biomarker analysis
- Keywords
- adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute myeloid leukemia in remission, untreated adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, untreated childhood acute myeloid leukemia and other myeloid malignancies
- Medical subject headings
- Leukemia, Leukemia, Promyelocytic, Acute
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity
Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro
Evaluation of the impact of S100A10 knockdown on fibrinolytic activity
Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jason N. Berman, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232855
- Sponsor's protocol ID
- AAML11B5
- Other IDs
- COG-AAML11B5, NCI-2011-02844, AAML11B5
- Status last verified
- May 2015
- First submitted
- 30 Oct 2010
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of S100A10 by the PML-RAR-alpha Oncoprotein
- ClinicalTrials.gov ID
- NCT01232855
- Acronym / sponsor ID
- AAML11B5
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute myeloid leukemia in remission, untreated adult acute myeloid leukemia, childhood acute myeloid leukemia in remission, untreated childhood acute myeloid leukemia and other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 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 fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia.
Detailed description
OBJECTIVES:
- Demonstrate that S100A10 is expressed on APL cells and that levels of S100A10 correspond to the amount of fibrinolytic activity.
- Evaluate the impact of ATRA on S100A10 level and fibrinolytic activity in vitro.
- Evaluate the impact of S100A10 knockdown on fibrinolytic activity.
- Correlate in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy.
OUTLINE: This is a multicenter study.
Previously collected samples are analyzed via flow cytometry and western blot analysis. Cell surface levels of S100A10 and annexin A2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin A2 and S100A10 in acute promyelocytic leukemia cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Acute Promyelocytic 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 |
|---|---|---|
| protein expression analysis | Genetic | – |
| western blotting | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity
Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro
Evaluation of the impact of S100A10 knockdown on fibrinolytic activity
Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy
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 2 Oct 2015.
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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.
Jason N. Berman, MD principal investigator
IWK Health Centre
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 2 Oct 2015. 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?
Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity. 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 2 Oct 2015.