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Clinical study of combined VIM and AL021918.2 gene methylation test for non-invasive diagnosis of urothelial carcinoma

Clinical validity study of the combined VIM and AL021918.2 gene methylation test kit (fluorescent PCR method)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078302
Enrollment
Unknown
Registered
2023-12-04
Start date
2023-11-22
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Interventions

Gold Standard:The clinical reference standard for patients with urothelial carcinoma, benign tumours of the urinary tract and other interfering cancers is pathological diagnosis, and patients with oth
Index test:Combined urine VIM and AL021918.2 gene methylation test

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients meeting any one of the following conditions can be included: (1) Patients with suspected symptoms of urinary tract epithelial cancer such as gross or microscopic hematuria, lumbar discomfort, urinary tract irritation symptoms, etc. (2) Patients with highly suspected or diagnosed urinary tract epithelial cancer based on clinical examination. (3) Patients with benign urinary system diseases (including benign urinary tract tumors, urinary calculi, effusion, infection, benign prostatic hyperplasia, cystitis, ureteritis, prostatitis, etc.) who plan to undergo or have already undergone imaging/endoscopic examination of the urinary system. (4) Untreated patients with other malignant tumors (including prostate cancer, renal cancer, colorectal cancer, cervical cancer, gastric cancer, liver cancer, lung cancer, breast cancer, thyroid cancer, etc.). (5) Postoperative urinary tract epithelial cancer patients who have undergone radical surgery for urinary tract epithelial cancer (with preoperative evaluation reagent detection).

Exclusion criteria

Exclusion criteria: Patients meeting any of the following conditions can be excluded: (1) Patients who have undergone surgery, radiotherapy/chemotherapy or other anti-tumor treatments in the past three months (except patients for preoperative and postoperative comparative studies); (2) Urinary tract epithelial cancer complicated with other malignant tumors (except for cases where primary urinary tract epithelial cancer has metastasized to other organs); (3) Samples not preserved as required; (4) The collected sample volume does not meet the detection requirements.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive coincidence rate;Negative coincidence rate;

Countries

China

Contacts

Public ContactXuesong Li

Peking University First Hospital

pineneedle@sina.com+86 158 0139 9116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026