Testing a urine DNA kit for diagnosing bladder cancer in China
A Multicenter, Single-blind, Observational Clinical Trial of URISAFE
This study is testing a new urine DNA kit to see if it can help diagnose bladder cancer more accurately than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 482 (estimated) |
| Sex | All |
| Sponsor | Creative Biosciences (Guangzhou) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05337189 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of a Human Multigene Methylation Detection Kit using Fluorescent PCR Method for diagnosing bladder cancer. Participants will provide urine samples, which will be analyzed for gene methylation levels and compared against standard diagnostic methods such as medical imaging, cystoscopy, and pathological examination. The study will involve blinded assessments to ensure unbiased results, and statistical analysis will be used to determine the kit's effectiveness in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with or suspected of bladder cancer, those with high-risk factors, or patients exhibiting hematuria symptoms.
Not a fit: Patients who have undergone surgery or chemoradiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive and accurate method for diagnosing bladder cancer, potentially improving early detection and patient outcomes.
How similar studies have performed: Other studies have shown promise in using urine DNA testing for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Subject must meet all three of the following criteria to be eligible for the study:
1. Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
2. Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
3. Any subject who is required to meet any of the following conditions:
1. Who is diagnosed with or suspected of bladder cancer.
2. Who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.).
3. Who has hematuria symptoms (such as cystitis, stones, etc.).
4. Who has other diseases that can be easily confused with bladder cancer.
Exclusion Criteria:
* Subject with any of the following conditions shall be excluded:
1. Who has undergone surgery or chemoradiotherapy.
2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Peng Du, PhD — Peking University Cancer Hospital & Institute
- Study coordinator: Xianshu Wang, PhD
- Email: xianshuwang@creativebio.cn
- Phone: 86-01-18819269978
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.