Diagnostic Study of Gene Alterations in Patients With Acu... | NCT00003931

ID	Type	Description	Link
U10CA031946	U.S. NIH Grant/Contract		View source
CLB-9769
CDR0000067123	Registry Identifier	NCI Physician Data Query

Status Module

Record Verification Date

Jul 2016

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

Feb 1999

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Nov 1, 1999

First Submission Date that Met QC Criteria

Aug 19, 2003

First Posted Date

Aug 20, 2003Estimated

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

Jul 1, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).
Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.

OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.

Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9,769Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood or bone marrow samples		All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected CALGB-9769. Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.	Genetic: reverse transcriptase-polymerase chain reaction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
reverse transcriptase-polymerase chain reaction	Genetic		blood or bone marrow samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
frequency of partial tandem duplication of ALL1 (MLL)		Up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
predictive value of partial tandem duplication of ALL1		Up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Prior registration on protocol CALGB-9665
Diagnosed with acute myeloid leukemia (AML)
Treated on a CALGB AML treatment protocol
Diagnostic bone marrow or blood specimen available

PATIENT CHARACTERISTICS:

Age:

15 and over

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients previously enrolled on CALGB-9665.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael A. Caligiuri, MD	Ohio State University Comprehensive Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veterans Affairs Medical Center - Birmingham		Birmingham	Alabama	35233-1996	United States
University of California San Diego Cancer Center

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D015470	Leukemia, Myeloid, Acute

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid

ID	Term
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques