NCT01232855

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 2, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

October 30, 2010

Last Update Submit

September 30, 2015

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 remissionuntreated adult acute myeloid leukemiachildhood acute myeloid leukemia in remissionuntreated childhood acute myeloid leukemia and other myeloid malignancies

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

protein expression analysisGENETIC
western blottingGENETIC
flow cytometryOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

LeukemiaLeukemia, Promyelocytic, Acute

Interventions

Blotting, WesternFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid, AcuteLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometry

Study Officials

  • Jason N. Berman, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2010

First Posted

November 2, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 2, 2015

Record last verified: 2015-05