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NCT Number: NCT06193941

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

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.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

RT-qPCR

Diagnostic Test

RT-qPCR

Primary outcomes

  1. RT-qPCR

    Time frame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.

    Urine exosomal RNA

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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