Gene Expression in Samples From Patients With T-Cell Acut... | NCT01520246

Studies
Gene Expression in Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

NCT01520246

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Leukemia
Lymphoma

Interventions

gene expression analysis
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-AALL12B2	Other Identifier	Children's Oncology Group
CDR0000723902	Other Identifier	clinicaltrials.gov
AALL12B2	Other Identifier	COG
NCI-2012-00241	Registry Identifier	CTRP (Clinical Trial Reporting Program)

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

Jan 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Jan 26, 2012

First Submission Date that Met QC Criteria

Jan 26, 2012

First Posted Date

Jan 27, 2012Estimated

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 7, 2016

Last Update Posted Date

Jul 11, 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 and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES:

To test whether the tumor suppressor candidate gene PDLIM2 is downregulated in human cancers such as T-cell acute lymphoblastic leukemia (T-ALL) and to use the human T-lymphotropic virus 1 (HTLV-1)-mediated in vitro transformation of human T cells as control.

OUTLINE: Previously collected cancer and control tissues are analyzed for the expression patterns of PDLIM2 and other control genes. Human T-cells isolated from human blood are also co-cultured with HTLV-1-transformed T-cell lines.

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PDLIM2 expression patterns in cancer and control tissues
8-week survival of human T-cell co-cultured with HTLV-1-transformed T-cell lines

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Specimens (e.g., tissue, blood, and bodily fluids) of various cancer cells and or tissues from de-identified patients such as T-cell acute lymphoblastic leukemia (T-ALL)
Normal control tissue

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

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients With T-Cell Acute Lymphoblastic Leukemia

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Gutian Xiao, MD	University of Pittsburgh	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D008223	Lymphoma
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D054218	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

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
D020869	Gene Expression Profiling

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
laboratory biomarker analysis	Other