Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

May 17, 2016 updated by: Children's Oncology Group

Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0

RATIONALE: Studying samples of blood and tumor 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.

PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.

OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.

Study Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enrolled on COG-ARAR0332

Description

DISEASE CHARACTERISTICS:

  • Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Identification of genetic factors affecting adrenocortical tumors
Comprehensive catalog of altered genes in adrenocortical samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gerard Zambetti, PhD, St. Jude Children's Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

February 5, 2012

First Submitted That Met QC Criteria

February 5, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAR12B1 (OTHER: Children's Oncology Group)
  • COG-ARAR12B1 (OTHER: Children's Oncology Group)
  • CDR0000724572 (OTHER: Clinical trials.gov)
  • NCI-2012-00244 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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