NCT01538823

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

February 20, 2012

Last Update Submit

January 4, 2019

Conditions

Keywords

Surgery, Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • evaluation of novel bio markers

    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.

    5 years

Study Arms (7)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Hu R, Gupta R, Wang Z, Wang C, Sun H, Singamaneni S, Kharasch ED, Morrissey JJ. Bioplasmonic paper-based assay for perilipin-2 non-invasively detects renal cancer. Kidney Int. 2019 Dec;96(6):1417-1421. doi: 10.1016/j.kint.2019.08.020. Epub 2019 Sep 3.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jerry Morrissey, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations