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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01505712
First received: January 4, 2012
Last updated: January 7, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Lymphoma
Genetic: gene expression analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Potential of gene expression profiling in changing treatment decision in cHL [ Designated as safety issue: No ]

Estimated Enrollment: 393
Study Start Date: December 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505712

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Randall D. Gascoyne, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01505712     History of Changes
Other Study ID Numbers: CDR0000720334, ECOG-E2496T1
Study First Received: January 4, 2012
Last Updated: January 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014