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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01366157
• Other study ID #: AHOD11B1
• Secondary ID: COG-AHOD11B1CDR0
• Status: Active, not recruiting
• Phase: N/A
• First received: June 2, 2011
• Last updated: May 5, 2015
• Start date: May 2011

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Genetic:
• microarray analysis

• protein expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)			No
Primary	Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL			No
Primary	Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL			No
Primary	Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression			No