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Human BHLHE40-ARL8B Gene Methylation Detection Kit (Fluorescent PCR Method)

Clinical Trial of Human BHLHE40-ARL8B Gene Methylation Detection Kit (Fluorescent PCR Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113280
Enrollment
Unknown
Registered
2025-11-26
Start date
2024-01-10
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Urothelium carcinoma

Interventions

Confirmed cases of urothelial carcinoma group:None
Urothelial carcinoma was excluded from the case group:None

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.The subjects should fall into any of the following categories: suspected individuals with urothelial carcinoma who have hematuria or bladder irritation symptoms such as frequent urination, urgent urination, and dysuria, or those whose diagnosis of urothelial carcinoma is unknown. The population diagnosed with urothelial carcinoma for the first time, including those diagnosed with bladder cancer or upper urothelial carcinoma. People with clinical symptoms of hematuria or bladder irritation symptoms such as frequent urination, urgent urination and painful urination, and diagnosed with benign lesions of the urinary system. People who are initially diagnosed with other malignant tumors of the urinary system that are not urothelial carcinoma. 2. Voluntarily participate in this clinical trial and be able to enroll urine samples before undergoing surgical treatment. 3. The clinical background information is complete, including the basic information of the subjects (gender, age, etc.) and the background information of clinical diagnosis.

Exclusion criteria

Exclusion criteria: 1. Samples of subjects who cannot be sampled due to their own diseases, incomplete case information, and samples that cannot be traced; 2. If any of the sample collection, transportation or storage does not comply with the requirements of the evaluation reagent product manual; 3. Patients with a history of urothelial carcinoma; 4. Patients with other tumors complicated with urothelial carcinoma; 5. Subjects who the researchers consider unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
DNA methylation analysis ;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactXue Wei

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

uroxuewei@163.com+86 138 0193 1604

Outcome results

None listed

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