Biomarkers in Tissue Samples From Patients With Acute Pro... | NCT01232855

Studies
Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia

NCT01232855

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Oct 2, 2015Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Leukemia

Interventions

protein expression analysis
western blotting
flow cytometry
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
COG-AAML11B5	Other Identifier	Children's Oncology Group
NCI-2011-02844	Registry Identifier	CTRP (Clinical Trial Reporting Program)
AAML11B5	Other Identifier	Children's Oncology Group

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Oct 30, 2010

First Submission Date that Met QC Criteria

Oct 30, 2010

First Posted Date

Nov 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2015

Last Update Posted Date

Oct 2, 2015Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
protein expression analysis	Genetic
western blotting	Genetic
flow cytometry	Other
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients With Acute Promyelocytic Leukemia

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jason N. Berman, MD	IWK Health Centre	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D015473	Leukemia, Promyelocytic, Acute

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015153	Blotting, Western
D005434	Flow Cytometry

Ancestor Terms

ID	Term
D004586	Electrophoresis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D055664	Electrochemical Techniques

Browse Leaves

Not provided

Browse Branches

Not provided