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Biomarker Correlates of Radiologic Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01538810
First received: February 20, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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
Abdominal CT Imaging Performed as Standard of Care

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Biomarker Correlates of Radiologic Imaging

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Quantitative measures [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    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:
  • differentiation of cancerous from non-cancerous renal mass [ Time Frame: at analysis ] [ Designated as safety issue: No ]
    Correct determination of tumor burden and differentiation of cancerous from non-cancerous renal mass.


Enrollment: 751
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01538810     History of Changes
Other Study ID Numbers: 201201061
Study First Received: February 20, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
CT imaging

ClinicalTrials.gov processed this record on November 25, 2014