Bladder CancerNCT05503563
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
An observational study of Bladder Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
In Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- terta modal bladder preservation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2022to 15 Sep 2024
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient presented with bladder cancer whom are under treatment with multiple modalities such as endoscopic resection , chemotherapy , radiotherapy \& partial cystectomy,
Who may be able to join
- Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface.
- Tumor at least 2 cm away from bladder neck or trigone.
- Clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after NAC at restaging TURBT (if done).
- Pathologically confirmed urothelial carcinoma.
Who cannot join
- Prescence of CIS.
- Presence of distant metastasis.
- Patients unfit for cisplatin-based chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
In Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year.
About 25% of new diagnoses are muscle-invasive bladder cancer (MIBC), which carry a worse prognosis compared to non-muscle invasive disease.
Read more
Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines.
However, this is associated with a significant impact on quality of life.
The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival?
Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection, allowing the confirmation of CRT response pathologically. In the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence, suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT.
Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC.
- Conditions
- Bladder Cancer
- Being tested
- terta modal bladder preservation
- Keywords
- Tetramodal bladder preservation, urothelial carcinoma, partial cystectomy
- 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.
terta modal bladder preservationProcedure or surgery
neoadjuvant chemotherapy, partial cystectomy, radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| tetra modal bladder preservation | Not described Receives: Procedure: terta modal bladder preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence rate
the patient will be evaluated using MRI and cystoscopy
Measured: the patient will be evaluted after partial cystectomy every 3 months for 2 years
over active bladder symptom score
the patient will be asked about his symptoms using a questionnaire that is concerned about urgency , frequency , urge incontinence .
Measured: this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start15 Jul 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Atef Ali, Assiut University
- Investigators
- Diaa A Sayed, PhD, Study director, cheif of urological oncology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503563
- Sponsor's protocol ID
- AssuitUUro
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Felix AS, Soliman AS, Khaled H, Zaghloul MS, Banerjee M, El-Baradie M, El-Kalawy M, Abd-Elsayed AA, Ismail K, Hablas A, Seifeldin IA, Ramadan M, Wilson ML. The changing patterns of bladder cancer in Egypt over the past 26 years. Cancer Causes Control. 2008 May;19(4):421-9. doi: 10.1007/s10552-007-9104-7. Epub 2008 Jan 10.
PubMed 18188671Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25.
PubMed 22877502Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.
PubMed 30763236Noone AM, Cronin KA, Altekruse SF, Howlader N, Lewis DR, Petkov VI, Penberthy L. Cancer Incidence and Survival Trends by Subtype Using Data from the Surveillance Epidemiology and End Results Program, 1992-2013. Cancer Epidemiol Biomarkers Prev. 2017 Apr;26(4):632-641. doi: 10.1158/1055-9965.EPI-16-0520. Epub 2016 Dec 12.
PubMed 27956436Singh AK, Shukla PK, Khan SW, Rathee VS, Dwivedi US, Trivedi S. Using the Modified Clavien Grading System to Classify Complications of Percutaneous Nephrolithotomy. Curr Urol. 2018 Feb;11(2):79-84. doi: 10.1159/000447198. Epub 2017 Dec 30.
PubMed 29593466
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder
- ClinicalTrials.gov ID
- NCT05503563
- Acronym / sponsor ID
- AssuitUUro
- Conditions
- Bladder Cancer
- Keywords
- Tetramodal bladder preservation, urothelial carcinoma, partial cystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 16 Aug 2022 (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.
In Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year.
About 25% of new diagnoses are muscle-invasive bladder cancer (MIBC), which carry a worse prognosis compared to non-muscle invasive disease.
Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines.
However, this is associated with a significant impact on quality of life.
The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival?
Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection, allowing the confirmation of CRT response pathologically. In the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence, suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT.
Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tetra modal bladder preservation | – | Procedure: terta modal bladder preservation |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient presented with bladder cancer whom are under treatment with multiple modalities such as endoscopic resection , chemotherapy , radiotherapy \& partial cystectomy,
Key inclusion criteria (4 listed)
- Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface.
- Tumor at least 2 cm away from bladder neck or trigone.
- Clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after NAC at restaging TURBT (if done).
- Pathologically confirmed urothelial carcinoma.
Key exclusion criteria (3 listed)
- Prescence of CIS.
- Presence of distant metastasis.
- Patients unfit for cisplatin-based chemotherapy.
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 |
|---|---|---|
| terta modal bladder preservationneoadjuvant chemotherapy, partial cystectomy, radiotherapy | Procedure or surgery | tetra modal bladder preservation |
Primary outcome
local recurrence rate
Time frame: the patient will be evaluted after partial cystectomy every 3 months for 2 years
the patient will be evaluated using MRI and cystoscopy
over active bladder symptom score
Time frame: this questionnaire will be carried every 6 month for at least 2 years after the partial cystectomy
the patient will be asked about his symptoms using a questionnaire that is concerned about urgency , frequency , urge incontinence .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 18188671Felix AS, Soliman AS, Khaled H, Zaghloul MS, Banerjee M, El-Baradie M, El-Kalawy M, Abd-Elsayed AA, Ismail K, Hablas A, Seifeldin IA, Ramadan M, Wilson ML. The changing patterns of bladder cancer in Egypt over the past 26 years. Cancer Causes Control. 2008 May;19(4):421-9. doi: 10.1007/s10552-007-9104-7. Epub 2008 Jan 10.
- Background: PubMed 22877502Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25.
- Background: PubMed 30763236Kulkarni GS, Black PC, Sridhar SS, Kapoor A, Zlotta AR, Shayegan B, Rendon RA, Chung P, van der Kwast T, Alimohamed N, Fradet Y, Kassouf W. Canadian Urological Association guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2019 Aug;13(8):230-238. doi: 10.5489/cuaj.5902. No abstract available.
- Background: PubMed 27956436Noone AM, Cronin KA, Altekruse SF, Howlader N, Lewis DR, Petkov VI, Penberthy L. Cancer Incidence and Survival Trends by Subtype Using Data from the Surveillance Epidemiology and End Results Program, 1992-2013. Cancer Epidemiol Biomarkers Prev. 2017 Apr;26(4):632-641. doi: 10.1158/1055-9965.EPI-16-0520. Epub 2016 Dec 12.
- Background: PubMed 29593466Singh AK, Shukla PK, Khan SW, Rathee VS, Dwivedi US, Trivedi S. Using the Modified Clavien Grading System to Classify Complications of Percutaneous Nephrolithotomy. Curr Urol. 2018 Feb;11(2):79-84. doi: 10.1159/000447198. Epub 2017 Dec 30.
- 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.
Diaa A Sayed, PhD study director
cheif of urological oncology department
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 Assiut 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 3 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 16 Aug 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 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 Abdelrahman Atef Ali, master degree (00201000318832, Abdelrahman_atefuro93@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate (time frame: the patient will be evaluted after partial cystectomy every 3 months for 2 years). The study lists 2 primary outcomes in all. 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 NCT05503563, which also lists 5 linked publications.
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 16 Aug 2022.