Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01366157
First received: June 2, 2011
Last updated: May 13, 2016
Last verified: May 2016
  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
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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 Children's Oncology Group:

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 ]

Biospecimen Retention:   Samples With DNA
Tissue

Enrollment: 23
Study Start Date: May 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with low-risk classical Hodgkin lymphoma
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Frank G. Keller, MD Emory Children's Center - Atlanta
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01366157     History of Changes
Other Study ID Numbers: AHOD11B1  COG-AHOD11B1  CDR0000701020  NCI-2011-02859 
Study First Received: June 2, 2011
Last Updated: May 13, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 28, 2016