Bladder Cancer Transitional Cell CarcinomaNCT01551342
Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
An observational study of Bladder Cancer Transitional Cell Carcinoma, run by Zetiq Technologies at 7 sites in Israel.
Trial summary
This study includes two semi-consecutive parts: Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Transitional Cell Carcinoma
- How many people
- 500 participants
- Where
- 7 sitesIsrael
- Study dates
- Jan 2012to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Who may be able to join
- Subjects meeting the following criteria (all of them) will be included in the study:
- Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
- At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
- Ability to provide informed consent
- Age ≥ 18 years old
Who cannot join
- Participation in another clinical trial within last 30 days.
- Known pregnancy on day of screening.
- Part B:
- Subjects complying with any of the following exclusion criteria will be excluded from the study:
- Subject with catheters, neobladder or kidney stones.
- Subject unable to provide a spontaneous urine sample.
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- Subject currently under any cancer drug treatment.
- No biopsy results available for subjects with positive findings on cystoscopy test, TURBT or cystectomy. [Note: such subjects will be excluded after recruitment and urine collection, as result of the delay in receiving biopsy results].
- If more than 3 months have passed between urine sample collection and TURBT or cystectomy procedures, and no second sample was taken before undergoing TURBT, subject will be excluded from the study.
- Subject undergoing TURBT or cystectomy whose biopsy results demonstrated abnormal findings other than TCC.
- Subject participated in another clinical study within the last 30 days.
- Known pregnancy on day of screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Israel7 sites, 7 recruiting
- Not yet recruiting
Emek Medical Center
Afula
Michael Cohen, Dr., +972-46494305/6
Michael Cohen, Dr.
- Recruiting
Urology Department, Bnai Zion Medical Center
Haifa
Ofer Nativ, Prof., 972-4-8359523, ofer.nativ@b-zion.org.il
- Recruiting
Urology Department, Hadassah Medical Center Ein Kerem
Jerusalem
Ofer Gofrit, Prof., 972-2-6510785, ogofrit@gmail.com
- Recruiting
Urology Department, Meir Medical Center
Kfar Saba
Ilan Leibovitch, Prof., 972-9-7471557, leibovitchi@clalit.org.il
- Recruiting
Urology Department, Rabin Medical Center, Belinson Campus
Petah Tikva
Ofer Yossepowitch, Dr, 972-3-9376553, oferu@clalit.org.il
- Recruiting
Urology Department, Sourasky Medical Center
Tel Aviv
Haim Matzkin, Prof., 972-3-6973265, hmatzkin@tamc.health.gov.il
- Recruiting
Urology Department, Sheba Medical Center
Tel HaShomer
Yoram Mor, Prof., 972-35302413, yoram.mor@sheba.health.gov.il
About this study
- This study includes two semi-consecutive parts:
- Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
- Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in patients with a history of TCC, using urine cytology samples
- The following subjects will be enrolled:
Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Read the detailed description
Study aim:
- To calibrate the CellDetect® device for detecting TCC in urine cytology samples.
- Determine the performance of the CellDetect® device in identifying TCC recurrence in patients with a history of TCC using urine cytology samples.
The study includes two parts:
Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in in patients with a history of TCC, using urine cytology samples
- The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Part I - up to 200 urine eligible samples Part II - up to 300 urine eligible samples
Endpoints:
- To calibrate the CellDetect® device for identifying TCC in urine cytology samples.
- To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.
- Keywords
- bladder cancer, Transitional cell carcinoma (TCC)
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopic surveillance, TURT or Cystectomy | The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Transitional Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zetiq Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551342
- Sponsor's protocol ID
- ZT-CL-04B
- Status last verified
- Aug 2013
- First submitted
- 7 Mar 2012
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Zetiq's Novel Cell Detect Technology For Detection Of Bladder Cancer In Urine Cytology
- ClinicalTrials.gov ID
- NCT01551342
- Acronym / sponsor ID
- ZT-CL-04B
- Keywords
- bladder cancer, Transitional cell carcinoma (TCC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zetiq TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- First posted
- 12 Mar 2012 (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.
- This study includes two semi-consecutive parts:
- Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
- Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in patients with a history of TCC, using urine cytology samples
- The following subjects will be enrolled:
Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Detailed description
Study aim:
- To calibrate the CellDetect® device for detecting TCC in urine cytology samples.
- Determine the performance of the CellDetect® device in identifying TCC recurrence in patients with a history of TCC using urine cytology samples.
The study includes two parts:
Part I Open label, controlled, Calibration part aimed to calibrate the CellDetect® device for identifying bladder cancer cells in urine samples.
Part II Prospective, controlled, blinded part to determine the performance of the CellDetect® device in monitoring bladder cancer recurrence in in patients with a history of TCC, using urine cytology samples
- The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Part I - up to 200 urine eligible samples Part II - up to 300 urine eligible samples
Endpoints:
- To calibrate the CellDetect® device for identifying TCC in urine cytology samples.
- To determine the performance of the CellDetect® device in identifying recurrence of TCC in urine samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystoscopic surveillance, TURT or Cystectomy | – | –The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The following subjects will be enrolled: Subjects previously diagnosed with bladder cancer undergoing routine cystoscopic surveillance, TURT or Cystectomy.
Key inclusion criteria (5 listed)
- Subject with a documented history of TCC and who are undergoing routine cystoscopic surveillance, TURBT or cystectomy
- At least 4 weeks have passed since any treatment for TCC (including cystoscopy and/or TURBT procedures)
- Ability to provide informed consent
- Age ≥ 18 years old
Key exclusion criteria (12 listed)
- Participation in another clinical trial within last 30 days.
- Known pregnancy on day of screening.
- Subjects complying with any of the following exclusion criteria will be excluded from the study:
- Subject with catheters, neobladder or kidney stones.
- Subject unable to provide a spontaneous urine sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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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.
Urology Department, Hadassah Medical Center Ein Kerem
Jerusalem, Israel
7 sites 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 Transitional Cell Carcinoma, run by Zetiq Technologies at 7 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 21 Mar 2014.