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Human FGFR3/TERT Gene Mutation and ONECUT2/VIM Gene methylation Detection Kit (PCR Fluorescent Probe Method)

Human FGFR3/TERT Gene Mutation and ONECUT2/VIM Gene methylation Detection Kit (PCR Fluorescent Probe Method)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076543
Enrollment
Unknown
Registered
2023-10-11
Start date
2023-02-28
Completion date
Unknown
Last updated
2023-10-16

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:Cases of urothelial carcinoma and other tumors are diagnosed through pathological diagnosis, while other diseases such as urinary tract stones and prostate hyperplasia are diagnosed thro
Index test:Human FGFR3/TERT Gene Mutation and ONECUT2/VIM Gene methylation Detection Kit (PCR Fluorescent Probe Method),DNA mutation analysis
Human FGFR3/TERT Gene Mutation and ONECUT2/VIM Gene methylation Detection Kit (PCR Fluorescent Probe Method),DNA methylation analysi

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 92 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, gender is not limited; (2) can provide not less than 100mL morning urine sample; (3) Sign the informed consent document; (4) One of the following conditions must be met: a. Subjects with pathologically confirmed urothelial carcinoma; b. Subjects who have been pathologically diagnosed with malignant tumors other than urothelial carcinoma; c. Subjects clinically diagnosed with benign urinary diseases, including urinary calculi, prostatic hyperplasia, renal cysts or other benign lesions; d. Subjects for whom the clinician recommends cystoscopy, ureteroscopy, or transurethral resection of bladder tumors.

Exclusion criteria

Exclusion criteria: Subjects with any of the following criteria were excluded from the study: (1) Previous history of malignant tumor; (2) Subjects with other systemic tumors combined with urothelial carcinoma; (3) Unable to sample or sample unqualified; (4) Failure to sign the informed consent document; (5) Subjects that the investigator considers it inappropriate to continue to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
DNA mutation analysis;DNA methylation analysis;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactDingwei Ye

Fudan University Shanghai Cancer Center

ydw@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026