Urinary Bladder Squamous Cell CarcinomaNCT04815629
Outcome of Radiation Therapy in Urinary Bladder Squampus Cell Carcinoma
An observational study of Urinary Bladder Squamous Cell Carcinoma, run by Assiut University.
Trial summary
Detection of distribution of clinico-pathological features of squamous cell carcinoma of urinary bladder and their relation to treatment outcome. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder Squamous Cell Carcinoma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with urinary bladder squamous cell carcinoma recieved radiotherapy .
Who may be able to join
- age 18-70 .
- histologically proved urinary bladder squamous cell carcinoma.
- non-metastatic disease.
- all patients who underwent radical treatment or bladder preserving approach.
- patient with isolated urinary bladder carcinoma (no other or previous primary).
Who cannot join
- age < 18 , > 70.
- patient not documented having bladder squamous cell carcinoma by biopsy (cystoscopic or operative).
- metastatic disease.
- patient with synchronous or metachronous double primary
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcome of Radical Radiation Therapy in Squampus Cell Carcinoma
Detection of distribution of clinico-pathological features of squamous cell carcinoma of urinary bladder and their relation to treatment outcome.
- Conditions
- Urinary Bladder Squamous Cell Carcinoma
- Being tested
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotion therapy squamous cell carcinoma in cancer bladder
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
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 Urinary Bladder Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Anter Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815629
- Sponsor's protocol ID
- Radiotherapy in bladder cancer
- Status last verified
- Aug 2021
- First submitted
- 23 Mar 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Messing EM. Urothelial tumours of the bladder. In: Wein AJ, Kavoussi LR, Novick AC, Partn AW, Peters CA (editors). Campbell-Walsh Urology. 9th(3). Philadelphia: Saunders Elsevier 2007: pp.2407-2446. 2. Christopher Ho Chee Kong, Praveen Singam, Goh Eng Hong, Lee Boon Cheok, Muhammad Azrif, Azmi Mohd Tamil et.al (2010). Clinicopathological features of bladder tumours in a single insttuton in Malaysia. Asian Pasifc J cancer Prev. 2010; 11: 149-152. 3. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ (2009). Cancer statstcs. CA Cancer J Clin. 2009 ; 59: 529-533. 4.Zarzour AH , Selim M, Abd -Elsayed A et al., muscle invasive bladder cancer in uppr Egypt : the shift in risk factors and tumor characteristics, license Bio Med central BMC Cancer doi.:10.1186 / 1471-2407-8-250-,2008. 5.Amal S. Ibrahim, Nabiel N Mikhail et al . Egypt National Cancer Registry Damietta profile - 2009: publication number RR2 July, 2011. 6.M.Nabil El- Bolkiny , M.Akram Nouh , Tarek N.El-Bolkiny et al.topographic pathology of cancer , the national cancer institute, Cairo University , 2008. 7.Jason A.Efstathiou, Anthony L.Zietman, Jhon J. Coen, clinical Radiation Oncology , bladder cancer ;3rd edition : p1216-1241, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Radical Radiation Therapy in Squampus Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04815629
- Acronym / sponsor ID
- Radiotherapy in bladder cancer
- Conditions
- Urinary Bladder Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 25 Mar 2021 (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.
Detection of distribution of clinico-pathological features of squamous cell carcinoma of urinary bladder and their relation to treatment outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with urinary bladder squamous cell carcinoma recieved radiotherapy .
Key inclusion criteria (5 listed)
- age 18-70 .
- histologically proved urinary bladder squamous cell carcinoma.
- non-metastatic disease.
- all patients who underwent radical treatment or bladder preserving approach.
- patient with isolated urinary bladder carcinoma (no other or previous primary).
Key exclusion criteria (4 listed)
- age < 18 , > 70.
- patient not documented having bladder squamous cell carcinoma by biopsy (cystoscopic or operative).
- metastatic disease.
- patient with synchronous or metachronous double primary
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 |
|---|---|---|
| RadiotherapyRadiotion therapy squamous cell carcinoma in cancer bladder | Radiation | – |
Primary outcome
Disease free survival
Time frame: baseline
Disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background1. Messing EM. Urothelial tumours of the bladder. In: Wein AJ, Kavoussi LR, Novick AC, Partn AW, Peters CA (editors). Campbell-Walsh Urology. 9th(3). Philadelphia: Saunders Elsevier 2007: pp.2407-2446. 2. Christopher Ho Chee Kong, Praveen Singam, Goh Eng Hong, Lee Boon Cheok, Muhammad Azrif, Azmi Mohd Tamil et.al (2010). Clinicopathological features of bladder tumours in a single insttuton in Malaysia. Asian Pasifc J cancer Prev. 2010; 11: 149-152. 3. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ (2009). Cancer statstcs. CA Cancer J Clin. 2009 ; 59: 529-533. 4.Zarzour AH , Selim M, Abd -Elsayed A et al., muscle invasive bladder cancer in uppr Egypt : the shift in risk factors and tumor characteristics, license Bio Med central BMC Cancer doi.:10.1186 / 1471-2407-8-250-,2008. 5.Amal S. Ibrahim, Nabiel N Mikhail et al . Egypt National Cancer Registry Damietta profile - 2009: publication number RR2 July, 2011. 6.M.Nabil El- Bolkiny , M.Akram Nouh , Tarek N.El-Bolkiny et al.topographic pathology of cancer , the national cancer institute, Cairo University , 2008. 7.Jason A.Efstathiou, Anthony L.Zietman, Jhon J. Coen, clinical Radiation Oncology , bladder cancer ;3rd edition : p1216-1241, 2012.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Squamous Cell Carcinoma, run by Assiut University.
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 4 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Aya Anter Ali, master degree (+201120516228, antaraya333@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815629, 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 18 Aug 2021.