Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology

An observational study of Bladder Cancer, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of the study is to develop a novel approach to obtain real time optical biopsy of urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel fibered confocal microscope. Read more about this study

Who is it for?: Any age
Conditions the study is for: Bladder Cancer
What is being tested?: Fibered confocal microscope
Type of treatment: Medical device
How many people: 195 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Feb 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Inclusion Criteria:Research subjects with suspected urinary tract pathology (e.g., bladder tumors) who are scheduled to undergo cystoscopy with possible excisional biopsy (e.g. transurethral resection of bladder tumor) in the operating room.\
 Exclusion Criteria:History of hypersensitivity to fluorescein; active urinary tract infection; pregnant; currently breast feeding;

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System
Palo Alto, California, 94304

Other trials in United States

About this study

Conditions: Bladder Cancer
Being tested: Fibered confocal microscope
Medical subject headings: Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fibered confocal microscopeDevice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Feb 2015

First posted3 Dec 2008 (estimated)
Study startSep 2008
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00801762
Sponsor's protocol ID: SU-10142008-1319
Status last verified: Apr 2019
First submitted: 2 Dec 2008
Last updated: 22 Apr 2019
Results posted: No

Publications

Sonn GA, Jones SN, Tarin TV, Du CB, Mach KE, Jensen KC, Liao JC. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. J Urol. 2009 Oct;182(4):1299-305. doi: 10.1016/j.juro.2009.06.039. Epub 2009 Aug 14.
PubMed 19683270

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology
ClinicalTrials.gov ID: NCT00801762
Acronym / sponsor ID: SU-10142008-1319
Conditions: Bladder Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Mauna Kea Technologies
Study start: Sep 2008 (actual)
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 3 Dec 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fibered confocal microscope	Device	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
Derived from this study: PubMed 19683270Sonn GA, Jones SN, Tarin TV, Du CB, Mach KE, Jensen KC, Liao JC. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. J Urol. 2009 Oct;182(4):1299-305. doi: 10.1016/j.juro.2009.06.039. Epub 2009 Aug 14.

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph C. Liao principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.