Bladder CancerNCT03148158
Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
An observational study of Bladder Cancer and Flexible Cystoscopy, run by Mansoura University at 1 site in Egypt.
Trial summary
This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Flexible Cystoscopy, Non-muscle Invasive Bladder Cancer (NMIBC)
- What is being tested?
- Cystoscopy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 15 Jun 2019
- 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: All patients diagnosed with suspected denovo, recurrent bladder mass or hematuria needing assessment by flexible cystoscopy will be asked to participate in this study at Urology and Nephrology Center Outpatient Clinics and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
Who may be able to join
- Men and women 18 years or older
- Denovo or recurrent NMIBC
- Bladder mass discovered in hematuria investigation
- Willing to share in study
Who cannot join
- inability to cooperate with flexible cystoscopic evaluations
- cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
- Untreated infections
- Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
- Unpassable urethral stricture
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516
Abdelwahab R. Hashem, Msc, 00201069678979, abdelwahab_hashem@yahoo.com
Mohammed H. Zahran, MD, 00201063338690, zahranmha@yahoo.com
About this study
This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.
Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.
In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.
- Conditions
- Bladder Cancer, Flexible Cystoscopy, Non-muscle Invasive Bladder Cancer (NMIBC), Pain, Postoperative
- Being tested
- Cystoscopy
- Keywords
- Bladder Cancer, Flexible cystoscopy, Diagnosis
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Pain, Postoperative, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystoscopyDevice
Outpatient flexible cystoscopy and inpatient rigid cystoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
Outcome measures by histopathological results of bladder biopsy
Measured: 1 year
Secondary outcomes (3)
Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy
Outcome measures by visual analog scale (VAS) pain score
Measured: 1 year
Assessment of the patient reported outcomes after both flexible and rigid cystoscopy
Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire
Measured: 1 year
Assessment of the prognostic value of gross morphology with recurrence, progression
Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start15 Jan 2018 (estimated)
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Hassan Abol-Enein, MD, Study chair, Urology and Nephrology centerAhmed Mosbah, MD, Study director, Urology and Nephrology centerMohamed Abdelbaset, Msc, Principal investigator, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148158
- Sponsor's protocol ID
- F-Cystoscopy NMIBC
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
- ClinicalTrials.gov ID
- NCT03148158
- Acronym / sponsor ID
- F-Cystoscopy NMIBC
- Conditions
- Bladder Cancer, Flexible Cystoscopy, Non-muscle Invasive Bladder Cancer (NMIBC), Pain, Postoperative
- Keywords
- Bladder Cancer, Flexible cystoscopy, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 10 May 2017 (actual)
- 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 will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.
Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.
In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with suspected denovo, recurrent bladder mass or hematuria needing assessment by flexible cystoscopy will be asked to participate in this study at Urology and Nephrology Center Outpatient Clinics and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
Key inclusion criteria (4 listed)
- Men and women 18 years or older
- Denovo or recurrent NMIBC
- Bladder mass discovered in hematuria investigation
- Willing to share in study
Key exclusion criteria (5 listed)
- inability to cooperate with flexible cystoscopic evaluations
- cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
- Untreated infections
- Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
- Unpassable urethral stricture
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 |
|---|---|---|
| CystoscopyOutpatient flexible cystoscopy and inpatient rigid cystoscopy | Device | – |
Primary outcome
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
Time frame: 1 year
Outcome measures by histopathological results of bladder biopsy
3 secondary outcomes
Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy
Time frame: 1 year
Assessment of the patient reported outcomes after both flexible and rigid cystoscopy
Time frame: 1 year
Assessment of the prognostic value of gross morphology with recurrence, progression
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
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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.
Hassan Abol-Enein, MD study chair
Urology and Nephrology center
Ahmed Mosbah, MD study director
Urology and Nephrology center
Mohamed Abdelbaset, Msc principal investigator
Urology and Nephrology Center
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 and Flexible Cystoscopy, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 5 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 9 Jan 2018. 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 Egypt. 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?
Contact Abdelwahab R. Hashem, Msc (01069678979 ext. 002, abdelwahab_hashem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents (time frame: 1 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 9 Jan 2018.