Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01146223
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 10
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Promyelocytic Leukemia (M3); Childhood Acute Promyelocytic Leukemia (M3)	Other: laboratory biomarker analysis

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:

1. 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational - WT-1's Role in Leukemogenesis
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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; Correlative studies

Outcome Measures

Primary Outcome Measures

1. WT1 and VEGF-1 expression [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of acute promyelocytic leukemia [t(15;17) translocation]

• Not specified

• Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Oncology Group	Monrovia	California	United States	91006-3776

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mustafa Moazam, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01146223
• Other Study ID Numbers: AAML10B7; NCI-2012-02717; CDR0000671471
• First Posted: Jun 17, 2010
• Last Update Posted: May 7, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute

Study Results

No Results Posted as of May 7, 2015