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A new type of urothelial tumour kit for the early diagnosis of urothelial carcinoma: a multi-centre prospective study

A new type of urothelial tumour kit for the early diagnosis of urothelial carcinoma: a multi-centre prospective study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078125
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

urothelial carcinoma

Interventions

Sponsors

Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Case group: 1. Male or female patient aged 18 or older; 2. Able to provide a 30 mL pre-treatment sample of morning or midstream urine; 3. Diagnosed as uroepithelial carcinoma of the bladder, ureter or renal pelvis by surgical pathology or biopsy pathology; 4. Patients with first diagnosis, without history of antitumor treatment, including antitumor drug therapy, surgical treatment, endocrine therapy, radiotherapy, etc., or no previous tumor history or postoperative and tumor recurrence. Control group: 1. Male or female patient aged 18 or older; 2. Patients able to provide a 30 mL pre-treatment sample of morning or mid-stream urine while receiving conventional treatment; 3. Diagnosed as urological malignancies by surgical pathology or biopsy pathology, other than urothelial carcinoma, including squamous cell carcinoma, adenocarcinoma of the bladder or other bladder-related cancers/prostate cancer/renal cancer; or clinically diagnosed with benign urological conditions, including urinary stones, urinary tract infections (other than urinary tract tuberculosis), prostatic hyperplasia. Healthy population: 1. Male or female patient aged 18 or older; 2. Able to provide a 30 mL morning or midstream urine sample within 1 month of physical examination; 3. Normal results of routine urinalysis/urinary ultrasound and no tumors in other organs.

Exclusion criteria

Exclusion criteria: 1. Patients with history of malignancy other than urological tumor; 2. Patients with history of antitumor treatment; 3. Patients unable to adhere to follow-up visits.

Design outcomes

Primary

MeasureTime frame
DNA methylation;accuracy;Sensitivity;specificity;

Secondary

MeasureTime frame
DNA mutation;pathological examination;Urological imaging;urine cytology;Cystoscopy;

Countries

China

Contacts

Public ContactFubo Wang

Guangxi Medical University

wangbofengye@163.com+86 135 8555 1316

Outcome results

None listed

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