- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01453465
Biomarker Study in Samples From Patients With Malignant Rhabdoid Tumor of the Kidney or Atypical Teratoid Rhabdoid Tumor
August 3, 2018 updated by: Children's Oncology Group
Gene Expression (GE) and MicroRNA (MIRNA) Expression Profiles of Malignant Rhabdoid Tumors (MRT) of the Kidney (RTK) and Atypical Teratoid Rhabdoid Tumor (ATRT)
This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor.
Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT).
OUTLINE:
Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Childrens Oncology Group
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Description
Inclusion Criteria:
- Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)
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?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ancillary-Correlative (gene expression profile, miRNA profile)
Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.
|
Correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Molecular differences between RTK and the ATRT
Time Frame: Up to 3 months
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Simone Sredni, Children's Oncology Group
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 (Actual)
November 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 1, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 17, 2011
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 3, 2018
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABTR12B1 (Other Identifier: CTEP)
- NCI-2011-03468 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000712872
- COG-ABTR12B1
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.