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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01366170
Other study ID # ANHL11B1
Secondary ID COG-ANHL11B1NCI-
Status Completed
Phase N/A
First received June 2, 2011
Last updated May 17, 2016
Start date May 2011

Study information

Verified date May 2016
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 biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.


Description:

OBJECTIVES:

- To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).

- To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.

OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 20 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of anaplastic large cell lymphoma

- Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Genetic:
microarray analysis

protein expression analysis

western blotting

Other:
flow cytometry

immunohistochemistry staining method

laboratory biomarker analysis

mass spectrometry


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 Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL No
Primary Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131 No
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