A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

Launched by CREATIVE BIOSCIENCES (GUANGZHOU) CO., LTD. · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new urine test called the Human Multigene Methylation Detection Kit, which aims to help diagnose bladder cancer more effectively. The researchers want to see how safe and accurate this urine test is compared to standard methods like medical imaging (such as MRI and CT scans) and procedures where a doctor looks inside the bladder (cystoscopy). The trial is currently looking for participants across multiple centers in China.

To be eligible for this study, participants should be anyone who is willing to take part and sign consent. They should also be diagnosed with or suspected of having bladder cancer, have high-risk factors for the disease, or show symptoms like blood in the urine. However, individuals who have had recent surgery or treatment for cancer, or those with other serious health conditions, won’t be able to join. Participants can expect to undergo standard tests and provide urine samples for this new test, helping researchers learn more about its effectiveness and safety.

Gender

ALL

Eligibility 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.