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NCT Number: NCT01505712

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Potential of gene expression profiling in changing treatment decision in cHL

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2012
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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