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New treatment option for Bladder Cancer
Official title Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC
ClinicalTrials.gov ID: NCT05123625
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or...
- Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent...
- Benefit from radical cystectomy as assessed by the investigator.
- Meeting the indications for the procedure: a) absolute neutrophil count ≥ 1.5 \ 109/L; b) platelets ≥ 100 \ 109/L; c) hemoglobin ≥ 90 g/L; d)...
- No previous history of tumor, lymph node dissection, or immune system-related disease.
You likely can't join if
- Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI;
- The investigator assessed patients who could not tolerate radical cystectomy;
- Previous systemic chemotherapy or immunotherapy;
- The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and...
- Had undergone major surgery or major trauma within 28 days before enrollment;
- Received live vaccine within 28 days before enrollment;
See the full eligibility criteria
- Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS...
- Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with \>3 cm in diameter. And no...
- Benefit from radical cystectomy as assessed by the investigator.
- Meeting the indications for the procedure: a) absolute neutrophil count ≥ 1.5 \ 109/L; b) platelets ≥ 100 \ 109/L; c) hemoglobin ≥ 90 g/L; d) international normalized ratio or activated partial thromboplastin time ≤ 1.5...
- No previous history of tumor, lymph node dissection, or immune system-related disease.
- Age 18 to 75 years.
- No neoadjuvant therapy.
- ECOG physical status 0 or 1.
- Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule.
- Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI;
- The investigator assessed patients who could not tolerate radical cystectomy;
- Previous systemic chemotherapy or immunotherapy;
- The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants;
- Had undergone major surgery or major trauma within 28 days before enrollment;
- Received live vaccine within 28 days before enrollment;
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment;
- Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment;
- Participating in other clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.