Urine Proteome of Surgical Patients and Healthy Volunteers (UP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01538823
First received: February 20, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of Renal Cell Carcinoma (RCC) with subsequent development of reliable, cost-effective, screening techniques.


Condition
Renal Cell Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urine Proteome of Surgical Patients and Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • evaluation of novel bio markers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The overall objective of our study is to find and evaluate additional novel biomarkers, predictive of disease, that are present and measurable in whole urine of patients undergoing surgery for renal cancer.


Estimated Enrollment: 836
Study Start Date: February 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Enrollment of surgical patients at Barnes Jewish Hospital (BJH) with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy.
Group 2
Surgical patients at BJH with non urological cancers
Group 3
Surgical patients at BJH with a presumptive diagnosis of RCC and planned nephrectomy or partial nephrectomy
Group 4
Surgical patients at BJH with non urological cancers
Group 5
Healthy volunteers with no history of cancer or renal disease
Group 6
Patients at BJH/Washington University School of Medicine under post procedure surveillance for RCC recurrence and patients under treatment for metastatic disease.
Group 7
Patients with a presumptive diagnosis of bladder cancer or prostate cancer

  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

Patients scheduled to have full or partial kidney removal surgery (possibly because of kidney cancer).

Patients scheduled to have a procedure because you may have bladder or prostate cancer.

Patients scheduled to have some other type of surgery (non-urological). Healthy volunteers

Criteria

Inclusion Criteria:

  • 18 years and older
  • Planned procedure with presumptive diagnosis of RCC, bladder or prostate cancer OR control patient undergoing non-urological surgery OR normal healthy volunteer OR post surgical patient with a diagnosis of RCC and under surveillance for reoccurrence of RCC or treatment of metastatic RCC
  • 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: NCT01538823

Contacts
Contact: Karen Frey 314-454-5980 freyk@anest.wustl.edu
Contact: Kalin Guebert 314-747-1663 kguebert@anest.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Jerry Morrissey, PhD         
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: NCT01538823     History of Changes
Other Study ID Numbers: 201202051
Study First Received: February 20, 2012
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Surgery, Renal Cell Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014