Protein Biomarker Levels in Tissue Samples From Young Pat... | NCT01366157

Studies
Protein Biomarker Levels in Tissue Samples From Young Patients With Low-risk Hodgkin Lymphoma

NCT01366157

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

23Actual

Phase

Not provided

Conditions

Lymphoma

Interventions

microarray analysis
protein expression analysis
immunohistochemistry staining method
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-AHOD11B1	Other Identifier	Children's Oncology Group
CDR0000701020	Other Identifier	Clinical Trials.gov
NCI-2011-02859	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 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

May 2011

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jun 2, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 3, 2011Estimated

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 13, 2016

Last Update Posted Date

May 17, 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 tissue from patients with cancer in the laboratory may help doctors identify and learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.

Detailed Description

OBJECTIVES:

To investigate the variability of expression of human geminal-center-associated lymphoma (HGAL) protein in pediatric low-risk Hodgkin lymphoma.
To assess the variability of HGAL staining between risk groups by comparing samples from subjects enrolled in the low-risk study AHOD0431 with subject samples enrolled in AHOD0031 for intermediate-risk classical Hodgkin Lymphoma (cHL).
To assess the variability of HGAL staining by evaluating a tissue array created from subjects with intermediate-risk cHL.
To correlate rapid or slow early-response in the intermediate-risk group with HGAL protein expression.

OUTLINE: Paraffin-embedded tissue samples and tissue microarrays are analyzed for protein expression by IHC.

Conditions Module

Conditions

Lymphoma

Keywords

childhood favorable prognosis Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
childhood lymphocyte depletion Hodgkin lymphoma
childhood lymphocyte predominant Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
childhood nodular lymphocyte predominant Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma

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

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microarray analysis	Genetic
protein expression analysis	Genetic
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)
Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL
Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL
Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosed with low-risk classical Hodgkin lymphoma (cHL)
Samples available from patients enrolled in the low-risk study COG-AHOD0431 and in the intermediate-risk cHL study COG-AHOD0031

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

21 Years

Standard Ages

ChildAdult

Study Population

Diagnosed with low-risk classical Hodgkin lymphoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank G. Keller, MD	Emory Children's Center - Atlanta	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046228	Microarray Analysis
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D046208	Microchip Analytical Procedures
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided