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BRIEF TITLE: Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer

Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer


  • Org Study ID: 170
  • Secondary ID:
  • NCT ID: NCT03125460
  • NCT Alias:
  • Sponsor: Cepheid - Industry
  • Source: Cepheid

Brief Summary

The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.

Overal Status Start Date Phase Study Type
Recruiting December 2016 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Comparison to histology for positive or suspicious cystoscopy

Primary Outcome 1 - Time Frame: Baseline = Subject Enrollment

Primary Outcome 2 - Measure: Comparison to histology for positive or suspicious cystoscopy

Primary Outcome 2 - Time Frame: Follow up = 12 months from Subject Enrollment (Baseline)

Condition:

  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Subject is ≥ 40 years of age

- Subject has provided documented informed consent as required by the reviewing IRB or
EC. Experimental Bill of Rights will be documented for all subjects enrolled in
applicable states.

- Subject is considered disease positive within 12 months (365 days) of enrollment.

- At the time of the enrollment visit, the subject is scheduled for a standard of care
cystoscopy which will be completed within 3 days of providing a urine specimen.

- Subject has agreed to provide at least 60 mL of voided urine for study purposes at the
enrollment visit.

- Subject has agreed to provide at least 60 mL of voided urine for study purposes at
each subsequent standard of care cystoscopy visit for at least 12 months (365 days)
following enrollment if the subject will enter the Longitudinal cohort.

- Any subject considered anticipatory positive at the initial visit shall be enrolled
into the longitudinal cohort. For each anticipatory positive enrolled into the
longitudinal cohort a random disease negative subject shall be enrolled.

Exclusion

- Subject has been previously enrolled into the study.

- Urine specimen to be used for study purposes is from the first morning void.

- Subject has had an excision procedure within six weeks (42 days) of enrollment.

- The subject is not scheduled for a standard of care cystoscopy visit within 12 months
(365 days) following enrollment.
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Gender: All

Minimum Age: 40 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Contact

Name: Andrew Hiar

Phone: 847-228-3292

Email: andrew.hiar@cepheid.com

Locations

Facility Status Contact
PAVA
Palo Alto, California 94304
United States
Recruiting Kathy Mach
650-849-1958
kmach@standford.edu
The Urology Center of Colorado, P.C.
Denver, Colorado 80211
United States
Recruiting Robin Dorsey
303-762-7155
Rdorsey@tucc.com
Urology Associates, P.C.
Englewood, Colorado 80113
United States
Recruiting Lenden Neeper
303-733-8848
L.Neeper@uradenver.com
North Idaho Urology
Coeur d'Alene, Idaho 83814
United States
Recruiting Chris Weber
208-415-1749
cweber@niurology.com
Idaho Urologic Institute
Meridian, Idaho 83642
United States
Recruiting Misty Pichardo
208-639-4946
mpichardo@idurology.com
UroPartners
Melrose Park, Illinois 60160
United States
Recruiting Michelle Johnson
708-681-4810
rmdresearch@sbcglobal.net
Five Valleys Urology
Missoula, Montana 59808
United States
Recruiting Michelle Brown
406-532-5676
michelle@fivevalleysurology.com
Weill Cornell Medicine
New York, New York 10065-4896
United States
Not yet recruiting Thomas Flynn
212-746-4739
thf3001@med.cornell.edu
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Jermeshia Barnes
405-271-8777
Jermeshia-Barnes@ouhsc.edu
UT Southwestern
Dallas, Texas 75390
United States
Recruiting Allison Beaver
214-645-8787
Allison.Beaver@UTSouthwestern.edu
Virginia Urology
Richmond, Virginia 23235
United States
Recruiting Nada Wood
804-288-2785
nada@uro.com
The Male/Female Health and Research Centre
Barrie, Ontario L4M 7G1 CA
Canada
Recruiting Karen Shirrif
(705) 727-0551
karenurology@pesmail.ca
G Kenneth Jansz Medicine Professional Corp.
Burlington, Ontario L7N 3V2
Canada
Recruiting Anna Krijan
905-681-9149
akrijan@bellnet.ca
Urology Associates / Urologic Medical Research
Kitchener, Ontario N2N 2B9 CA
Canada
Recruiting Blair Egerdie
(519) 578-0470
blairegerdie@mac.com
Urology Clinic of Dr. Goldfarb
North Bay, Ontario P1B 7K8
Canada
Recruiting Terri Moreau
(705) 482-1063
drgoldfarb@bellnet.ca
Urologic Clinic of Stanley Flax
North York, Ontario M2J 1V1
Canada
Recruiting Tracy Hobbins
416-499-1333
Radboud University Medical Center
Nijmegen, 6525GA
Netherlands
Recruiting Caroline Sieverink
31243610502
Caroline.Sieverink@radboudumc.nl