Urinary Bladder CancerNCT05946369
Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
An observational study of Urinary Bladder Cancer and Urinary Bladder Neoplasm, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder). In this study, the investigators will link the Neutrophils to Lymphocytes ratio to the response to intravesical BCG therapy post trans-urethral resection of urinary bladder tumors for the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Bladder Cancer, Urinary Bladder Neoplasm, BCG
- What is being tested?
- Neutrophil to lymphocyte ratio
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with intermediate and high-risk group of non-muscle invasive urothelial tumor will be included in our study. They will go through detailed history taking, general and local examinations. Routine Labs (specially CBC with Differential Count) preoperatively will be done to all patients during the surgery workup. Histopathology report of the first resection and another one of the check cystoscopy to confirm the primary diagnosis. BCG course ( once weekly for 6 weeks) 2-6 weeks after resection as an induction course. Then maintaince doses for 1-3 years based on the European Association of Urology recommendations. Follow up cystoscopy will be scheduled based on the European association of Urology schedule for intermediate and high risk groups.
Who may be able to join
- Patients with non-muscle invasive urothelial tumor of the urinary bladder
Who cannot join
- Concomitant malignancy.
- Hematological disorders.
- History of radiation or chemotherapy.
- Concomitant infection or chronic inflammatory diseases.
- Missing preoperative differential blood cell count.
- Patients with low grade non muscle invasive Urinary baldder tumors.
- Patients missing BCG after biopsy revealing NMIBC.
- patients with non-compliance to BCG doses or the scheduled follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
There is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder).
In this study, the investigators will link the Neutrophils to Lymphocytes ratio to the response to intravesical BCG therapy post trans-urethral resection of urinary bladder tumors for the non-invasive urinary bladder tumors.
Read the detailed description
The gold standard treatment for non-invasive urinary bladder tumors is by transurethral resection of bladder tumor (TURBT) and a re-TURBT when indicated, followed by adjuvant intravesical immunotherapy (BCG). However, the recurrence and progression rates of non-muscle invasive bladder cancer (NMIBC) for 5 years range from 31% to 78% and from 1% to 45%, respectively.
To improve personalized care, prognostic models have been developed to help in prediction of the high-risk patients and recurrence helping in clinical and therapeutic decision-making. These models are based on standard clinic-pathological features such as T stage, grade, multifocality, sex, tumor diameter, recurrence rate, and concomitant carcinoma in situ.
According to the current theories, the systemic inflammatory response triggered by cancer leads to relative neutrophilia and lymphocytopenia, creating a pro-oncogenic inflammatory condition. An elevated NLR (Neutrophil to lymphocyte ratio) implies that cell-mediated immunity is impaired and systemic inflammation is increased in inflammatory processes. Among patients with non-invasive urinary bladder tumors, an elevated NLR (Neutrophil to lymphocyte ratio) was described in the literature to be associated with advanced pathologic stage, invasiveness, and bad prognosis.
The study aims to assess the role of preoperative Neutrophils to Lymphocytes ratio as a predictor for the response to BCG in patients with non-muscle invasive bladder cancer in patients following trans-urethral resection of bladder tumor (TURBT).
- Conditions
- Urinary Bladder Cancer, Urinary Bladder Neoplasm, BCG, Trans Urethral Resection of a Bladder Tumor, Non-Muscle Invasive Bladder Urothelial Carcinoma
- Being tested
- Neutrophil to lymphocyte ratio
- 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.
Neutrophil to lymphocyte ratioDiagnostic test
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient
| Study group | Role | What they receive |
|---|---|---|
| Neutrophil to lymphocyte ratio less than 3 | Patients are classified into 2 groups according to NLR < or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure Receives: Diagnostic Test: Neutrophil to lymphocyte ratio | |
| Neutrophil to lymphocyte ration more than or equal 3 | Patients are classified into 2 groups according to NLR < or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure Receives: Diagnostic Test: Neutrophil to lymphocyte ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCG failure
evaluation of tumor recurrence or progression post BCG intravesical instillation in our study population and draw up and correlation between BCG failure and Neutrophil to lymphocyte ratio
Measured: 3 years following tumor resection and BCG instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 May 2020
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946369
- Sponsor's protocol ID
- MS 475/ 2021
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05946369
- Acronym / sponsor ID
- MS 475/ 2021
- Conditions
- Urinary Bladder Cancer, Urinary Bladder Neoplasm, BCG, Trans Urethral Resection of a Bladder Tumor, Non-Muscle Invasive Bladder Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 14 Jul 2023 (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.
There is a relation between inflammatory cells and the prognosis of tumors (cancer colon, renal, liver, and urinary bladder).
In this study, the investigators will link the Neutrophils to Lymphocytes ratio to the response to intravesical BCG therapy post trans-urethral resection of urinary bladder tumors for the non-invasive urinary bladder tumors.
Detailed description
The gold standard treatment for non-invasive urinary bladder tumors is by transurethral resection of bladder tumor (TURBT) and a re-TURBT when indicated, followed by adjuvant intravesical immunotherapy (BCG). However, the recurrence and progression rates of non-muscle invasive bladder cancer (NMIBC) for 5 years range from 31% to 78% and from 1% to 45%, respectively.
To improve personalized care, prognostic models have been developed to help in prediction of the high-risk patients and recurrence helping in clinical and therapeutic decision-making. These models are based on standard clinic-pathological features such as T stage, grade, multifocality, sex, tumor diameter, recurrence rate, and concomitant carcinoma in situ.
According to the current theories, the systemic inflammatory response triggered by cancer leads to relative neutrophilia and lymphocytopenia, creating a pro-oncogenic inflammatory condition. An elevated NLR (Neutrophil to lymphocyte ratio) implies that cell-mediated immunity is impaired and systemic inflammation is increased in inflammatory processes. Among patients with non-invasive urinary bladder tumors, an elevated NLR (Neutrophil to lymphocyte ratio) was described in the literature to be associated with advanced pathologic stage, invasiveness, and bad prognosis.
The study aims to assess the role of preoperative Neutrophils to Lymphocytes ratio as a predictor for the response to BCG in patients with non-muscle invasive bladder cancer in patients following trans-urethral resection of bladder tumor (TURBT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutrophil to lymphocyte ratio less than 3 | – | Diagnostic Test: Neutrophil to lymphocyte ratioPatients are classified into 2 groups according to NLR < or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure |
| Neutrophil to lymphocyte ration more than or equal 3 | – | Diagnostic Test: Neutrophil to lymphocyte ratioPatients are classified into 2 groups according to NLR < or ≥ 3 and follow up the 2 groups for recurrence or regression of bladder urothelial tumor and documentation of BCG failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with intermediate and high-risk group of non-muscle invasive urothelial tumor will be included in our study. They will go through detailed history taking, general and local examinations. Routine Labs (specially CBC with Differential Count) preoperatively will be done to all patients during the surgery workup. Histopathology report of the first resection and another one of the check cystoscopy to confirm the primary diagnosis. BCG course ( once weekly for 6 weeks) 2-6 weeks after resection as an induction course. Then maintaince doses for 1-3 years based on the European Association of Urology recommendations. Follow up cystoscopy will be scheduled based on the European association of Urology schedule for intermediate and high risk groups.
Key inclusion criteria (1 listed)
- Patients with non-muscle invasive urothelial tumor of the urinary bladder
Key exclusion criteria (8 listed)
- Concomitant malignancy.
- Hematological disorders.
- History of radiation or chemotherapy.
- Concomitant infection or chronic inflammatory diseases.
- Missing preoperative differential blood cell count.
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 |
|---|---|---|
| Neutrophil to lymphocyte ratioComplete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient | Diagnostic test | Neutrophil to lymphocyte ratio less than 3, Neutrophil to lymphocyte ration more than or equal 3 |
Primary outcome
BCG failure
Time frame: 3 years following tumor resection and BCG instillation
evaluation of tumor recurrence or progression post BCG intravesical instillation in our study population and draw up and correlation between BCG failure and Neutrophil to lymphocyte ratio
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 18 Jul 2023.
- Individual participant dataSharing planned: No
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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 Urinary Bladder Cancer and Urinary Bladder Neoplasm, run by Ain Shams 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 1 inclusion and 8 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 18 Jul 2023. 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?
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?
BCG failure (time frame: 3 years following tumor resection and BCG instillation). 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 18 Jul 2023.