Biomarker Correlates of Radiologic Imaging
This study is ongoing, but not recruiting participants.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01538810
First received: February 20, 2012
Last updated: April 11, 2013
Last verified: April 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 20, 2012 | ||||
| Last Updated Date | April 11, 2013 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01538810 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biomarker Correlates of Radiologic Imaging | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Anyone undergoing an abdominal image, meeting eligibility criteria. |
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| Condition ICMJE | Abdominal CT Imaging Performed as Standard of Care | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 751 | ||||
| Estimated Completion Date | February 2015 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01538810 | ||||
| Other Study ID Numbers ICMJE | 201201061 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Washington University School of Medicine | ||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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