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Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

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ClinicalTrials.gov Identifier: NCT01528956
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Adrenocortical Carcinoma Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: nucleic acid sequencing Genetic: polymorphism analysis

Detailed Description:


  • 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
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0
Study Start Date : February 2012
Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Identification of genetic factors affecting adrenocortical tumors
  2. Comprehensive catalog of altered genes in adrenocortical samples

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled on COG-ARAR0332


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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528956

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Gerard Zambetti, PhD St. Jude Children's Research Hospital

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01528956     History of Changes
Other Study ID Numbers: ARAR12B1
COG-ARAR12B1 ( Other Identifier: Children's Oncology Group )
CDR0000724572 ( Other Identifier: Clinical trials.gov )
ARAR12B1 ( Other Identifier: Children's Oncology Group )
NCI-2012-00244 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
adrenocortical carcinoma

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Adrenal Cortex Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases