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Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits

Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06193941
Enrollment
400
Registered
2024-01-05
Start date
2023-06-01
Completion date
2023-12-01
Last updated
2024-01-09

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

Conditions

Bladder Cancer, Urothelial Carcinoma

Brief summary

Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.

Detailed description

In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.

Interventions

DIAGNOSTIC_TESTRT-qPCR

RT-qPCR

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age ≥ 18 years with defined gender; 2. Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.

Exclusion criteria

1. Aged \<18 years; 2. Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy 3. History of other malignant tumors 4. Specimens with hemolytic conditions; 5. Patients with incomplete, undocumented, and uncooperative data.

Design outcomes

Primary

MeasureTime frameDescription
RT-qPCRUrine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.Urine exosomal RNA

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026