A Prospective, Multicenter Cohort Study of Urinary Exosome lncRNAs for Preoperative Diagnosis of Lymphatic Metastasis in Patients With Bladder Cancer

NCT05270174 | Unknown

• 1 other identifier: SYSEC-KY-KS-2021-278
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder cancer is one of the most frequent malignant tumors of the urinary system in China, seriously threatening the life safety of patients. The main treatment methods for bladder cancer include surgical resection, radiotherapy and chemotherapy, immunotherapy, and targeted therapy, among which surgical resection is still the only reliable radical treatment at present. Lymphatic metastasis is the main mode of metastasis of bladder cancer, and preoperative diagnosis is of great significance to determine whether radical surgical treatment can be performed for some patients with advanced bladder cancer. Recent studies reveal that exosomes, as key signaling molecules in the tumor microenvironment, have been confirmed to be associated with various tumor progressions. Our previous study showed that lncRNA-ELNAT1 highly expressed in urine exosomes of bladder cancer patients can promote lymphatic metastasis of bladder cancer by inducing lymphatic angiogenesis, and is associated with poor prognosis of patients. However, whether exosome ELNAT1 can be used as an independent preoperative predictor of lymph node metastasis of bladder cancer needs to be explored in further clinical trials, and this study will further clarify the association between the two. In this study, urine exosomes were collected from positive and negative control patients with lymph node metastasis of bladder cancer, and the ROC curve was statistically analyzed and fitted to determine whether exosome ELANT1 could be used as an independent predictor of lymph node metastasis of bladder cancer.

Conditions

Explore Whether lncRNA-ElNAT1 in Urine Exosomes Can be Used as a New Target for Preoperative Diagnosis of Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

• Lymph node metastases in bladder cancer

  Analyses of number and location of lymph node metastases based on pathological diagnosis

  1 years

Secondary Outcomes (1)

• recurernce rate

  3 years

Study Arms (2)

lncRNA-ELNAT1 high expression group

Other: no intervention

lncRNA-ELNAT1 low expression group

Other: no intervention

Interventions

no intervention OTHER

no intervention

lncRNA-ELNAT1 high expression group; lncRNA-ELNAT1 low expression group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patient diagnosed with bladder cancer

You may qualify if:

• Patients older than 18 years old
• Clinically diagnosed urothelial carcinoma bladder cancer
• Patients agreed to provide the urine sample
• Patients who voluntarily agreed to informed consent

You may not qualify if:

• Patients with distant metastasis
• Patients with uncontrolled viral infection (HIV, HBV, HCV)
• Patients who are pregnant, or have the possibility of pregnancy and are on lactating
• Hypersensitivity or history of allergic to the drug being used
• Patients with cerebrovascular disease, complications, and infections that are not medically controlled
• Patients with a history of other malignant diseases within the past 5 years (excluding cured non-melanoma skin cancer or in situ cervical cancer)
• Those who are taking drugs that can cause drug interactions with chemotherapy
• Patients who withdraw consent

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hosptial

Guangzhou, China

Location

Central Study Contacts

Changhao Chen

CONTACT

+86-13631412669; chenchh53@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 8, 2022
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 21, 2023

Record last verified: 2022-02

Locations

CN (1)