NCT01146223

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.

Trial Health

87
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 Sep 2009

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

June 16, 2010

Last Update Submit

May 6, 2015

Conditions

Adult Acute Myeloid LeukemiaAdult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Promyelocytic Leukemia (M3)Childhood Acute Promyelocytic Leukemia (M3)

Outcome Measures

Primary Outcomes (1)

  • WT1 and VEGF-1 expression

    Baseline

Study Arms (1)

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

laboratory biomarker analysisOTHER

Correlative studies

Basic science (correlative studies)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

acute promyelocytic leukemia

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mustafa Moazam, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

US(1)