Bladder CancerNCT02811952
Measuring Urinary Nano Particles and Metallic Compounds in TCC Patients
An observational study of Bladder Cancer, run by Carmel Medical Center at 1 site in Israel.
Trial summary
In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- without intervention
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Jun 2016to 1 Jan 2021
- 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: patients with bladder cancer \& control group
Who may be able to join
- Study group :
- Patients that need cystoscopy due to suspicion/known bladder malignancy.
- Patients that can read, understand and sign an informed consent form.
- Control group:
- Patients that need cystoscopy due to others reasons than malignancy.
- Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).
Who cannot join
- Study group:
- Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
- Patients with a technically improper urine test.
- Control group
- Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
- Patients with a technically improper urine test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.
- Conditions
- Bladder Cancer
- Being tested
- without intervention
- Keywords
- bladder cancer
- 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.
without interventionOther
without intervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Patients that need that need cystoscopy due to suspicion/known bladder malignancy. Receives: Other: without intervention | |
| control group | Patients that need cystoscopy due to others reasons than malignancy. Receives: Other: without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of nano particles and arsenic in urine
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start23 Jun 2016
- Primary completion31 Jul 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan Beniamin Klein, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811952
- Sponsor's protocol ID
- CMC-15-0127-CTIL
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2016
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Urinary Nano Particles and Arsenic and Comparing Them to Cystoscopic Findings and Urinary Cytology in Patients Suspected With Urinary Bladder Malignancy
- ClinicalTrials.gov ID
- NCT02811952
- Acronym / sponsor ID
- CMC-15-0127-CTIL
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 23 Jun 2016 (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.
In many of urothelial carcinoma patients, one does not find common risk factors such as smoking. The medical center is located in an industrial city with known air and water pollution. The investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. The patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: without interventionPatients that need that need cystoscopy due to suspicion/known bladder malignancy. |
| control group | – | Other: without interventionPatients that need cystoscopy due to others reasons than malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with bladder cancer \& control group
Key inclusion criteria (6 listed)
- Patients that need cystoscopy due to suspicion/known bladder malignancy.
- Patients that can read, understand and sign an informed consent form.
- Patients that need cystoscopy due to others reasons than malignancy.
- Patients that present to the Department of Urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, Incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc).
Key exclusion criteria (6 listed)
- Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
- Patients with a technically improper urine test.
- Control group
- Patients receiving bladder irrigations, pregnant women, children and those with impaired judgment
- Patients with a technically improper urine test.
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 |
|---|---|---|
| without interventionwithout intervention | Other | control group, study group |
Primary outcome
levels of nano particles and arsenic in urine
Time frame: one year
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 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Carmel Medical Center at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 14 Oct 2022. 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 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?
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.
What does the primary outcome measure?
levels of nano particles and arsenic in urine (time frame: one year). It is what the study was designed to measure, not a finding.
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 14 Oct 2022.