Neutrophils to Lymphocytes Ratio in Predicting the Response to BCG in Non-muscle Invasive Bladder Cancer
NCT ID: NCT05946369
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2020-05-01
2023-05-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Neutrophil to lymphocyte ratio
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient
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
Neutrophil to lymphocyte ratio
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient
Interventions
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Neutrophil to lymphocyte ratio
Complete blood count with differential to evaluate the Neutrophil to lymphocyte ratio for each patient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Hematological disorders.
3. History of radiation or chemotherapy.
4. Concomitant infection or chronic inflammatory diseases.
5. Missing preoperative differential blood cell count.
6. Patients with low grade non muscle invasive Urinary baldder tumors.
7. Patients missing BCG after biopsy revealing NMIBC.
8. patients with non-compliance to BCG doses or the scheduled follow up.
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ahmed Maher Gamil Ahmed Higazy
principle investigator
Locations
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Ain Shams university
Cairo, , Egypt
Countries
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Other Identifiers
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MS 475/ 2021
Identifier Type: -
Identifier Source: org_study_id
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