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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01623856
Other study ID # ANHL12B1
Secondary ID NCI-2012-01975
Status Completed
Phase N/A
First received June 15, 2012
Last updated May 6, 2015
Start date June 2012
Est. completion date June 2012

Study information

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

Clinical Trial Summary

This research studies genes associated with non-Hodgkin lymphoma in young patients. Studying samples of blood and 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


Description:

OBJECTIVES:

I. To conduct a preliminary investigation of the effects of loci strongly and consistently associated in prior genome-wide association studies (GWAS) and validation studies of childhood/adolescent acute lymphoblastic leukemia (ALL), adult non-Hodgkin lymphoma (NHL), autoimmune diseases, and atopic diseases on the risk of NHL (lymphoblastic and Burkitt lymphomas) in children and adolescents.

OUTLINE:

DNA samples are analyzed by single nucleotide polymorphism and genotyped by fluorogenic polymerase chain reaction (PCR)-based allelic discrimination (Taqman) assays using the ABI Prism 7900HT reverse transcriptase (RT)-PCR system.


Recruitment information / eligibility

Status Completed
Enrollment 483
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 20 Years
Eligibility Inclusion Criteria:

- Slides and/or other available specimens from patients diagnosed with lymphoblastic lymphoma (LL) or Burkitt lymphoma ( BL) enrolled on the Children Oncology Group (COG) protocols 5961, A5971, and ANHL01P1 collected at the time of diagnosis and currently housed at the Biopathology Center at Nationwide Children's Hospital

- Samples from non-Hispanic white patients

- DNA samples from 384 healthy, anonymous, non-Hispanic white blood donors used as controls

- See Disease Characteristics

- Not specified

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Intervention

Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Potential deviations from Hardy-Weinberg Equilibrium (HWE) Baseline No
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