NCT01385150

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

January 3, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2012

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

June 28, 2011

Last Update Submit

May 18, 2017

Conditions

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)untreated adult acute myeloid leukemiaadult acute basophilic leukemiaadult acute eosinophilic leukemiaadult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute minimally differentiated myeloid leukemia (M0)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult acute myeloblastic leukemia with maturation (M2)adult acute myeloblastic leukemia without maturation (M1)adult acute myelomonocytic leukemia (M4)

Outcome Measures

Primary Outcomes (1)

  • Absence of serum 2HG in all samples without an IDH mutation

    1 day

Secondary Outcomes (1)

  • Relationship between 2HG level and survival outcomes

    1 day

Interventions

Eligibility Criteria

Age17 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Samples from patients enrolled on E1900 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) * Newly diagnosed with AML * Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008 * Patients with or without isocitrate dehydrogenase (IDH) mutations PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Received 2 different doses of standard induction chemotherapy on ECOG-1900

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

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaCongenital AbnormalitiesLeukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, Acute

Interventions

Chromatography, LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

ChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Courtney DiNardo, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 29, 2011

Study Start

January 3, 2012

Primary Completion

February 3, 2012

Study Completion

February 3, 2012

Last Updated

May 19, 2017

Record last verified: 2017-05