NCT00897182

Brief Summary

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment. PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

May 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

May 9, 2009

Last Update Submit

July 1, 2016

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remissionadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(8;21)(q22;q22)childhood acute myeloid leukemia in remissionrecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiasecondary acute myeloid leukemiauntreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignancies

Outcome Measures

Primary Outcomes (4)

  • Correlation of increased or decreased expression of same transcripts with disease outcome

    baseline

  • Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia

    baseline

  • Identification of individual genes that are differentially expressed between the subtypes of AMLs

    baseline

  • Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations

    baseline

Study Arms (1)

Group 1

This is a CALGB Leukemia Tissue Bank project makes use of tissue from patients who have previously provided their consent. Diagnostic samples from patients enrolled on CALGB AML treatment studies (eg, CALGB 9621, 9710, and 19808) and who have been registered on the companion Leukemia Tissue Bank Protocol CALGB 9665 were used.

Genetic: microarray analysisGenetic: polymerase chain reaction

Interventions

microarray analysisGENETIC
Group 1
polymerase chain reactionGENETIC
Group 1

Eligibility Criteria

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

Patients diagnosed with acute myeloid leukemia.

* Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665 * Short-term or long-term survivor * Bone marrow and/or peripheral blood obtained at diagnosis * Leukemia is one of the following cytogenetic subtypes: * t(8;21) * t(15;17) * inv(16)

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

Sponsors & Collaborators

Study Sites (2)

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46845, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow and/or peripheral blood obtained at diagnosis from AML patients enrolled on CALGB AML treatment studies.

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

Microarray AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • Janet Rowley, MD

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

US(2)