Biomarkers in Samples From Patients With Down Syndrome an... | NCT01139307

Studies
Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia

NCT01139307

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Feb 23, 2016Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

cell culture procedure
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
COG-AAML10B1	Other Identifier	Children's Oncology Group
CDR0000671427	Other Identifier	Clinical Trials.gov
NCI-2011-02218	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Feb 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

Jul 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Not provided

First Submitted Date

Jun 5, 2010

First Submission Date that Met QC Criteria

Jun 5, 2010

First Posted Date

Jun 8, 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

Feb 19, 2016

Last Update Posted Date

Feb 23, 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: Studying samples of blood or tissue 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 research study is studying biomarkers in samples from patients with Down syndrome and acute megakaryoblastic leukemia.

Detailed Description

OBJECTIVES:

Determine whether megakaryocyte differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor can lead to proliferation arrest, polyploidization, and terminal differentiation of blasts in specimens from patients with Down syndrome and acute megakaryoblastic leukemia.

OUTLINE: Cryopreserved specimens are cultured and treated in vivo (in mice) and in vitro with megakaryocytic differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor.

Conditions Module

Conditions

Leukemia

Keywords

adult acute megakaryoblastic leukemia (M7)
childhood acute megakaryocytic leukemia (M7)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies

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

No data available

No data is available for this block.

Enrollment

10Estimated

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute megakaryoblastic leukemia
Diagnosis of Down syndrome
Cryopreserved specimens available

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

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Diagnosis of acute megakaryoblastic leukemia or diagnosis of Down syndrome when cryopreserved specimens are available.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Crispino, PhD	Robert H. Lurie Cancer Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D007947	Leukemia, Megakaryoblastic, Acute
D015470	Leukemia, Myeloid, 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
D018929	Cell Culture Techniques

Ancestor Terms

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Proliferation arrest
Polyploidization
Terminal differentiation

Name	Type	Description	Arm Group Labels	Other Names
cell culture procedure	Other
laboratory biomarker analysis	Other