Superficial Bladder Cancer t1aNCT04298073
Skipping BCG for T1a Urinary Bladder Tumor.
An observational study of Superficial Bladder Cancer t1a, run by Assiut University.
Trial summary
Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superficial Bladder Cancer t1a
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2020to 4 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients who attending our oncological urology outpatient clinic consented to participate in the study.
Who may be able to join
- The study will include all patients that diagnosed for the first time as T1a urothelial carcinoma .
Who cannot join
- Other variants of bladder cancer as squamous cell carcinoma of urinary bladder ,small cell carcinoma of urinary bladder, -sarcomatoid variant of urinary bladder \& anaplastic cell carcinoma of urinary bladder
- patients Who were previously treated for bladder cancer by any modality including TURT, BCG, chemotherapy and radiotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Skipping Maintenance BCG on the Recurrence and Progression of T1a Urinary Bladder Tumor.
Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .
Read the detailed description
Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .
- Conditions
- Superficial Bladder Cancer t1a
What is being measured
The primary outcome is the main question the study is designed to answer.
follow up
evaluation if there is recurrence or progression of T1a bladder tumor.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start4 Mar 2020 (estimated)
- Primary completion4 Mar 2022 (estimated)
- Study completion4 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Bladder Cancer t1aStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ali Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298073
- Sponsor's protocol ID
- new treatment bladder cancer
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skipping Maintenance BCG on the Recurrence and Progression of T1a Urinary Bladder Tumor.
- ClinicalTrials.gov ID
- NCT04298073
- Acronym / sponsor ID
- new treatment bladder cancer
- Conditions
- Superficial Bladder Cancer t1a
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Mar 2020 (estimated)
- Primary completion
- 4 Mar 2022 (estimated)
- Study completion
- 4 Apr 2022 (estimated)
- First posted
- 6 Mar 2020 (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.
Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .
Detailed description
Bladder cancer is the most common malignancy involving theurinary system and the ninth most common malignancy worldwide .In Egypt, the urinary bladder cancer accounted for about 31% of the total incidence of cancers that subsequently decreased to 12% in the recent years .Transitional cell (Urothelial) carcinoma is the most common type of bladder cancer, about more than 90% all bladder cancers . Other pathological types are less common such as squamous cell carcinoma (observed in about 5% of bladder cancers), adenocarcinoma (observed in approximately 1% of bladder cancers) and small cell carcinoma. Urothelial carcinomas are divided clinically into superficial tumors and muscle invasive tumors. Grossly they may appear in various forms, most commonly papillary, but may also appear as a nodule or an irregular solid growth .Accurate prediction of progression is essential need in T1 bladder cancer (BCa) because the stakes are high for this disease. About one-third of patients never recur after initial treatment, one-third have cancer that recurs as non-muscle invasive BCa (NMIBC), and one-third progress to muscle-invasive BCa with significantly worse clinical outcome . Recurrence and progression rates for pT1 tumors are highly variable Accurate prediction of progression is essential need in T1 bladder cancer management. There is difficulty in predication of T1 progression due to intrinsic difficulty in assessing the presence and extent of invasion. Patient prognosis and management have been affected by the Identification of the muscularis mucosa (MM) by Dixon and Gosling in 1983 . Elderly patients with bladder cancer frequently have comorbid conditions that make conservative management preferable for early invasive urothelial carcinomas. Several studies have explored the utility of evaluating the spatial relationship of invasive tumor to the Muscularis mucosa for sub classification of pT1 urothelial carcinomas . Muscularis mucosa consists of thin and wavy fascicles of smooth muscle frequently associated with large, thin-walled blood vessels in the submucosa of the bladder wall . It can be identified in 15-83% of biopsy specimens . T1 bladder staging has been changing and led to its classification into two groups: T1a (minimally invasive) tumors (i.e., tumors that extend into the lamina propria but are located above the level of the MM), and T1b (invasive) tumors (i.e., tumors that invade beyond the MM). Treatments for T1 bladder cancers are grouped into three categories. First, the tumour can be resected (TURBT) at the initial or restaging setting, which can be performed with white or blue-light cystoscopy. The second approach involves intravesical BCG administration with multiple years of maintenance therapy. Finally, aggressive or high risk T1 bladder cancers can be managed by radical cystectomy at 'early' or 'delayed' time points relative to diagnosis .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who attending our oncological urology outpatient clinic consented to participate in the study.
Key inclusion criteria (1 listed)
- The study will include all patients that diagnosed for the first time as T1a urothelial carcinoma .
Key exclusion criteria (2 listed)
- Other variants of bladder cancer as squamous cell carcinoma of urinary bladder ,small cell carcinoma of urinary bladder, -sarcomatoid variant of urinary bladder \& anaplastic cell carcinoma of urinary bladder
- patients Who were previously treated for bladder cancer by any modality including TURT, BCG, chemotherapy and radiotherapy
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
follow up
Time frame: 3 months
evaluation if there is recurrence or progression of T1a bladder tumor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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 Superficial Bladder Cancer t1a, 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 1 inclusion and 2 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 6 Mar 2020. 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 Ahmed M Ali, MD (01008181914, ahmedali-61988@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow up (time frame: 3 months). 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 6 Mar 2020.