Biomarkers in Bone Marrow Samples From Patients With Acut... | NCT01251159

Studies
Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia

NCT01251159

Sponsor

ECOG-ACRIN Cancer Research Group

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Leukemia

Interventions

mutation analysis
polymerase chain reaction
immunologic technique
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ECOG-E1900T4

Status Module

Record Verification Date

May 2017

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

May 15, 2009Actual

Primary Completion Date

Jun 15, 2009Actual

Completion Date

Jun 15, 2009Actual

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Nov 30, 2010

First Posted Date

Dec 1, 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 16, 2017

Last Update Posted Date

May 17, 2017Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is studying bone marrow samples from patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

To rigorously examine fractionated hematopoietic stem and progenitor cells from patients with acute myeloid leukemia (AML).
To define somatic mutations occurring in de novo AML, including the FLT3-ITD, CEBPA, NPM1, TET2, ASXL1, IDH1, and IDH2 mutations.
To examine what cellular compartments (LT-HSC, ST-HSC, CMP, GMP, and MEP) contain the selected mutations and in what order those mutations occur.

OUTLINE: Archived bone marrow specimens are analyzed for sequencing and detection of mutations by Sanger-based resequencing of PCR amplicons. Results are then compared with the results of age-matched healthy controls.

Conditions Module

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult 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 leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mutation analysis	Genetic
polymerase chain reaction	Genetic
immunologic technique	Other
laboratory biomarker analysis	Other

Measure	Description	Time Frame
Define somatic mutations occurring in de novo AML		1 month

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute myeloid leukemia
Bone marrow samples must meet 1 of the following criteria:
- Normal karyotype from patients enrolled on ECOG-1900 archived at the ECOG Leukemia Tissue Bank
  - Live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% DMSO OR fresh cells shipped immediately
- Age-matched healthy control samples from commercial providers

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich G. Steidl, MD, BS	Albert Einstein College of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D000013	Congenital Abnormalities
D015470	Leukemia, Myeloid, Acute
D015479	Leukemia, Myelomonocytic, Acute
D007948	Leukemia, Monocytic, Acute
D004915	Leukemia, Erythroblastic, Acute
D007947	Leukemia, Megakaryoblastic, Acute

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016133	Polymerase Chain Reaction
D007158	Immunologic Techniques

Ancestor Terms

ID	Term
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided