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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01366157
First received: June 2, 2011
Last updated: June 4, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Lymphoma
Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Investigation to Evaluate the Levels of Human Germinal-center-Associated Lymphoma (HGAL) Protein in Pediatric Hodgkin Lymphoma and Correlate With Early Response

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL) [ Designated as safety issue: No ]
  • Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL [ Designated as safety issue: No ]
  • Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL [ Designated as safety issue: No ]
  • Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Start Date: May 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01366157

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Frank G. Keller, MD Emory Children's Center - Atlanta
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01366157     History of Changes
Other Study ID Numbers: CDR0000701020, COG-AHOD11B1
Study First Received: June 2, 2011
Last Updated: June 4, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

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

ClinicalTrials.gov processed this record on August 28, 2014