Bladder urothelial carcinoma
Conditions
Interventions
Gold Standard:Guidelines for the diagnosis of bladder cancer, pathological diagnosis.
Index test:A novel screening model for urine methylation detection
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Eligibility Criteria for Bladder Cancer Patients: Age > 18 years, with no gender restrictions. Histopathologically confirmed diagnosis of bladder cancer. Newly diagnosed patients who have not undergone urinary system surgery or antitumor drug treatment. Normal blood routine, stool routine, liver and kidney function tests, and electrocardiogram. 2.Eligibility Criteria for Non-Cancer Urinary System Infection Patients: Age > 18 years, with no gender restrictions. No history of tumors. Meeting the diagnostic criteria for urinary system infection: urinary examination shows leukocyturia, i.e., non-centrifuged urine examination with white blood cells > 10 per µl, or urinary sediment microscopy with white blood cells > 5 per high-power field (HPF). At least one of the following symptoms or signs within 72 hours prior to screening: dysuria, frequency of urination, urgency, back pain, costovertebral angle tenderness, or suprapubic tenderness. Able to provide a clean midstream urine culture specimen within 48 hours prior to enrollment, with a urine culture result showing bacterial counts >=10^5 CFU/ml. 3.Eligibility Criteria for Healthy Participants: Age > 18 years, with no gender restrictions. No history of urinary system tumors. No urinary system symptoms such as dysuria, frequency of urination, urgency, suprapubic pain, or painful urination. No significant abnormalities in urine routine and renal function tests within 72 hours prior to screening.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for patients with bladder cancer: (1) patients with a history of other types of tumors, or patients who have received anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy, radiotherapy, etc., (2) patients who do not provide urine specimens for testing as required, (3) patients with severe heart, brain, liver, and kidney insufficiency, severe coagulation dysfunction or other symptoms that interfere with the judgment of the disease, (4) pregnant or lactating patients, (5) patients who are in poor general condition and cannot tolerate surgery, (6) insufficient clinical data, Patients who are unable to make clinical comparisons; 2. Exclusion criteria for patients with non-cancer urinary tract infections: (1) patients with a history of tumors, or patients receiving antimicrobial therapy, (2) patients who did not provide urine specimens for testing as required, (3) patients with severe heart, brain, liver, and kidney insufficiency, severe coagulation dysfunction or other symptoms that interfere with the judgment of the disease, (4) pregnant or lactating patients, (5) patients with poor general condition and unable to tolerate surgery, (6) patients with insufficient clinical data and unable to make clinical comparisons; 3. Exclusion criteria for healthy participants: Exclusion criteria: (1) patients with a history of tumors, (2) patients who did not provide urine specimens for testing as required, (3) patients with severe heart, brain, liver, and kidney insufficiency, severe coagulation dysfunction or other symptoms that interfere with the judgment of the condition, (4) pregnant or lactating patients, (5) patients with mental and cognitive impairments, and patients who cannot cooperate with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine DNA hydroxymethylation sequencing level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Accuracy; | — |
Countries
China
Contacts
Public ContactYin Liu, Zhenduo Shi
Xuzhou Central Hospital
Outcome results
None listed