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Trial record 4 of 4 for:    AQP1

Biomarker Correlates of Radiologic Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01538810
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date February 20, 2012
First Posted Date February 24, 2012
Last Update Posted Date June 17, 2016
Study Start Date February 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01538810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker Correlates of Radiologic Imaging
Official Title Biomarker Correlates of Radiologic Imaging
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Anyone undergoing an abdominal image, meeting eligibility criteria.
Condition Abdominal CT Imaging Performed as Standard of Care
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 11, 2013)
751
Original Estimated Enrollment
 (submitted: February 23, 2012)
1200
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients on dialysis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01538810
Other Study ID Numbers 201201061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Jerry Morrissey, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2016