Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT04947059
Eligibility Criteria:
Inclusion Criteria:
* Primary urinary bladder tumor
* Secondary urinary bladder tumor (recurrence)
* Bipolar or monopolar resection
* Creat \<2.2mg/dl
* 35% \<Hct \<52%
* White bloode cells count WBC ≥3000 / μL
* 75000 \<PLT \<500000 / μL
* Urine culture: negative / sterile
* Alkaline phosphatase, total bilirubin, SGOT, SGPT: values as high as 2 times above the upper normal limit
* Good clinical condition (according to Eastern Cooperative Oncology Group PS ≤ 1)
* CT Urography without findings suggesting an upper urinary tract tumor in the last 3 months before the transurethral resection of the bladder tumor
Exclusion Criteria:
* More than 2 low grade / high differentiation (low grade / LG) histologically confirmed bladder tumors in the last 18 months before the transurethral resection of the bladder tumor
* High grade / low differentiation (HG) histologically confirmed bladder tumor in the last 9 months before the transurethral resection of the bladder tumor
* Those who undergo a transurethral resection of a bladder tumor according to the Guidelines of the European Association of Urology for non-muscle-invasive bladder cancer: incomplete resection of tumor, absence of muscle fibers in the sample with the exception of: Ta / LG-G1, primary Cis and finally, pT1 tumors
* Intravesical instillation of chemotherapeutic agent or BCG in the last 6 months before the transurethral resection of the bladder tumor
* History of non-urothelial bladder cancer
* Stage of disease pT2 (muscle-invasive bladder cancer)
* Presence of a tumor in the urethra
* Upper urinary tract malignancy (present or anamnestically)
* History of pelvic radiotherapy
* Histrory of another malignancy in the last 5 years before the transurethral resection of the bladder tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04947059
Study Brief:
Protocol Section:
NCT04947059