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Biomarker Correlates of Radiologic Imaging

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ClinicalTrials.gov Identifier: NCT01538810
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assemble a collection of urine and blood samples for the development and validation of biomarkers potentially useful in correlating or improving the diagnostic utility of abdominal imaging.

Condition or disease
Abdominal CT Imaging Performed as Standard of Care

Study Design

Study Type : Observational
Actual Enrollment : 751 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Biomarker Correlates of Radiologic Imaging
Study Start Date : February 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Quantitative measures [ Time Frame: at enrollment ]
    Confirm the ability of quantitative measure of AQP-1 and ADFP by ELISA from urine and blood samples to develop and validate an assay for patients with renal cancer.


Secondary Outcome Measures :
  1. differentiation of cancerous from non-cancerous renal mass [ Time Frame: at analysis ]
    Correct determination of tumor burden and differentiation of cancerous from non-cancerous renal mass.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone undergoing an abdominal image, meeting eligibility criteria.
Criteria

Inclusion Criteria:

  • 18 years and older
  • Undergoing abdominal CT imaging (standard of care)
  • Signed, informed consent

Exclusion Criteria:

  • Patients on dialysis
Contacts and Locations

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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): NCT01538810


Locations
United States, Missouri
Washington University School Of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jerry Morrissey, PhD Washington University School of Medicine
More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01538810     History of Changes
Other Study ID Numbers: 201201061
First Posted: February 24, 2012    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016

Keywords provided by Washington University School of Medicine:
CT imaging