Actively Recruiting
Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-08-05
200
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
T
The Second Affiliated Hospital of Kunming Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.
CONDITIONS
Official Title
Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy suggestive of G3/high grade or carcinoma in situ or cystoscopic findings of multiple tumors larger than 3 cm, with VI-RADS score 1 or 2 and no enlarged lymph nodes on MRI
- Patients with pathologically confirmed high-risk NMIBC including stage T1, G3/high-grade, CIS, or multiple recurrent low-grade tumors over 3 cm, and no enlarged lymph nodes on MRI
- Assessed to benefit from radical cystectomy by the investigator
- Meeting blood count and organ function requirements suitable for major abdominal surgery
- No previous history of tumor, lymph node dissection, or immune system-related disease
- Age between 18 and 75 years
- No prior neoadjuvant therapy
- ECOG physical status 0 or 1
- Voluntary participation with ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Bladder cancer stage T2 or higher, or pelvic lymph node enlargement shown by MRI
- Unable to tolerate radical cystectomy as assessed by investigator
- Previous systemic chemotherapy or immunotherapy
- Active autoimmune diseases requiring systemic treatment or long-term use of immunosuppressants
- Major surgery or trauma within 28 days before enrollment
- Received live vaccine within 28 days before enrollment
- Severe infections requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days before enrollment
- Use of Chinese herbal or proprietary medicines for cancer control within 14 days before enrollment
- Participation in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
X
Xiao Yang, MD
CONTACT
J
Juntao Zhuang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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