Biomarkers in Tissue Samples From Patients With Hodgkin L... | NCT01505712

Studies
Biomarkers in Tissue Samples From Patients With Hodgkin Lymphoma Enrolled on ECOG-2496 Clinical Trial

NCT01505712

Sponsor

ECOG-ACRIN Cancer Research Group

Status

Completed

Last Update Posted

May 18, 2017Actual

Enrollment

393Actual

Phase

Not provided

Conditions

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	Link
ECOG-E2496T1

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

Dec 15, 2011Actual

Primary Completion Date

Nov 19, 2012Actual

Completion Date

Nov 19, 2012Actual

First Submitted Date

Jan 4, 2012

First Submission Date that Met QC Criteria

Jan 4, 2012

First Posted Date

Jan 6, 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

May 17, 2017

Last Update Posted Date

May 18, 2017Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

RATIONALE: Studying samples of 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. It may also help doctors find better ways to treat cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.

Detailed Description

OBJECTIVES:

To explore the predictive power of a gene expression-based multi-gene predictor in classical Hodgkin lymphoma (cHL) with the potential to change clinical practice by basing treatment decisions on biological markers.

OUTLINE: Archived tissue samples are analyzed for gene expression profile using NanoString technology. Results are then compared with patients' treatment outcomes, including failure-free survival and overall survival.

PROJECTED ACCRUAL: A total of 306 patients from ECOG-2496 (training cohort) and 87 patients treated with ABVD in other trials (validation cohort) will be accrued for this study.

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

393Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Potential of gene expression profiling in changing treatment decision in cHL		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Training cohort: Patients diagnosed with locally extensive and advanced stage classical Hodgkin lymphoma (cHL) and treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) or mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone (Stanford V)
- Pretreatment formalin-fixed, paraffin-embedded tissue (FFPET) from patients enrolled on the randomized phase III ECOG-2496 clinical trial
Validation cohort: Patients with advanced-stage cHL treated with ABVD at the British Columbia Cancer Agency (BCCA)
- Pretreatment FFPET available

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Samples from patients who participated in E2496 and provided samples for research.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randall D. Gascoyne, MD	British Columbia Cancer Agency	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
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