Biomarkers in Bone Marrow Samples From Patients With Acut... | NCT01146223

ID	Type	Description	Link
NCI-2012-02717	Registry Identifier	CTRP (Clinical Trial Reporting Program)
CDR0000671471	Other Identifier	Clinical Trials.gov

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

Sep 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 16, 2010

First Submission Date that Met QC Criteria

Jun 16, 2010

First Posted Date

Jun 17, 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

May 6, 2015

Last Update Posted Date

May 7, 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

This research study is studying biomarkers in patients with acute promyelocytic leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and about biomarkers related to cancer.

Detailed Description

OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples With DNA BIOSCPECIMEN DESCRIPTION: Bone marrow STUDY POPULATION DESCRIPTION: Primary Care Clinic SAMPLING METHOD: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To measure WT1 and VEGF-1 expression in patients with acute promyelocytic leukemia.

OUTLINE: This is a multicenter study.

Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.

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

Label	Type	Description	Intervention Names
Basic science (correlative studies)		Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.	Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Correlative studies	Basic science (correlative studies)

Measure	Description	Time Frame
WT1 and VEGF-1 expression		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of acute promyelocytic leukemia [t(15;17) translocation]
Not specified
Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

acute promyelocytic leukemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mustafa Moazam, MD	Children's Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Oncology Group		Monrovia	California	91006-3776	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D015470	Leukemia, Myeloid, Acute
D015473	Leukemia, Promyelocytic, Acute

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases