Research to develop diagnostic and therapeutic methods for cancer of the renal pelvis and ureter

JRCT ID: jRCT1030220502

Registered date:09/12/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Cancer of the renal pelvis and ureter
• Date of first enrollment: 09/12/2022
• Target sample size: 250
• Study type: Interventional
• Intervention(s): Upper urinary tract urine will be divided for this study in approximately 10 ml at the time of upper urine collection for patients for whom upper urinary cytology is deemed necessary for routine medical care. Natriuresis should be collected from the surplus of the specimen used in the usual practice. Or, if the urine collection is beyond the scope of usual practice, about 10 ml shall be collected.

Outcome(s)

• Primary Outcome: Exosomes extracted from urine samples will be analyzed using the ExoScreen method to evaluate differences in expression of specific exosomes between patients with renal pelvis or ureteral cancer and others.
• Secondary Outcome: In immunochemical staining of surgical specimens, the expression of target substances in cancer tissue, mainly nucleic acids and proteins including miRNAs in this study, will be compared with that in noncancer tissue.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who have visited the outpatient urology clinic, who are at least 20 years old, and whose urine can be collected.

Exclude criteria

1) Patients undergoing treatment for malignant diseases in other departments
2) Patients who are judged by the investigator to be unsuitable as subjects
3) Patients who have indicated that they will not cooperate in this study.

Related Information

• Primary Sponsor: Hayakawa Nozomi
• Source(s) of Monetary Support: Department's own funds