- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505712
Biomarkers in Tissue Samples From Patients With Hodgkin Lymphoma Enrolled on ECOG-2496 Clinical Trial
Outcome Prediction in Hodgkin Lymphoma by Low-Density Gene Expression Profiling of Formalin Fixed Paraffin Embedded Tissues: A Correlative Study of Inter-Group Trial E2496
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Potential of gene expression profiling in changing treatment decision in cHL
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Randall D. Gascoyne, MD, British Columbia Cancer Agency
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000720334
- ECOG-E2496T1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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