Cystoscopic Evaluation Before Surgery for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Prior pelvic irradiation, Pregnant, Nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

65 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, investigational study to assess the accuracy of standardized cystoscopic evaluation with tissue sampling performed immediately prior to definitive radical cystectomy to predict pathologic tumor stage and identify patients who may benefit from bladder preservation therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Radical Cystectomy for bladder cancer?

The research suggests that radical cystectomy, a surgery to remove the bladder, is a common treatment for bladder cancer, but it is associated with high rates of complications. Efforts to improve patient outcomes focus on preoperative optimization, such as nutritional evaluation and prehabilitation, which may help reduce complications and improve recovery. ^{1 2 3 4 5}

Is radical cystectomy generally safe for humans?

Radical cystectomy, a surgery for bladder cancer, is generally safe but can have complications. Common issues include infections and digestive problems, but these are usually manageable. The surgery is considered safe even for elderly patients at high risk. ^{6 7 8 9 10}

How does the treatment Radical Cystectomy differ from other treatments for bladder cancer?

Radical Cystectomy is a surgical procedure that involves the removal of the entire bladder and surrounding tissues, which is different from other treatments like chemotherapy or radiation that aim to target cancer cells without removing the bladder. This approach is typically used for more advanced bladder cancer when other treatments are not sufficient. ^{11 12 13 14 15}

Research Team

Alexander Kutikov, MD

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for adults over 18 with urothelial carcinoma stages T1-T4NanyM0, who are fit enough for surgery (ECOG status 0-3), and have decided on radical cystectomy. They must understand the study and consent to participate. Women of childbearing age should agree to use contraception. Excluded are those with non-curative intent, prior pelvic radiation, or who are pregnant/nursing.

Inclusion Criteria

I can care for myself but may not be able to do active work.

I can understand and am willing to sign the consent forms myself or have someone who can do it for me.

I am over 18 years old.

Exclusion Criteria

I have not had a cystectomy that was not aimed at curing my condition.

I am not pregnant or nursing, as the treatment would be risky for a fetus or infant.

I have had radiation treatment to my pelvic area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Sample Collection

Collection of urine, PBMC, and serum/plasma samples prior to any chemotherapy administration and prior to the procedure

1 day

1 visit (in-person)

Procedure Day

Standard rigid cystourethroscopy and tissue sampling performed immediately prior to radical cystectomy

1 day

1 visit (in-person)

Post-Procedure Follow-up

Collection of urine, PBMC, and serum/plasma samples at 4-6 weeks and 6 months post-procedure to monitor genomic changes

6 months

2 visits (in-person)

Long-term Follow-up

Monitoring of genomic tumor signatures and chemotherapy response up to 5 years post-surgery

5 years

Treatment Details

Interventions

• Radical Cystectomy

Trial Overview The study tests how well a standardized cystoscopic evaluation with tissue sampling before radical cystectomy can predict tumor stage and identify candidates for bladder preservation therapy. It's prospective, meaning it follows patients forward in time from the point of their evaluation through surgery.

Participant Groups

Group I: Surgical Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Temple University

Collaborator

Trials

321

Recruited

89,100+

Findings from Research

Radical cystectomy (RC) has high rates of complications and mortality, prompting a focus on preoperative optimization strategies to improve patient outcomes.

Current literature suggests that comprehensive nutritional evaluation, supplementation, and prehabilitation may help reduce the risks associated with RC, beyond standard enhanced recovery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative optimization of the radical cystectomy patient: Current state and future directions. Ellis, JL., Dalimov, Z., Chew, L., et al.[2023]

In a study of 196 patients who underwent robot-assisted radical cystectomy (RARC) for bladder cancer, 80% experienced some form of complication within 90 days post-surgery, highlighting the significant morbidity associated with this procedure.

Major complications occurred in 35% of patients, with the most common issues being infections and gastrointestinal problems, indicating that while RARC is a minimally invasive option, it still carries substantial risks that need careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. Yuh, BE., Nazmy, M., Ruel, NH., et al.[2022]

Hospital acquired adverse events occurred in 11.3% of patients undergoing radical cystectomy, significantly increasing the risk of in-hospital mortality (8.07 times higher) and leading to longer hospital stays (41.3% longer) and higher costs ($54,242 compared to $26,306).

Postoperative sepsis was particularly dangerous, associated with the highest mortality risk (17.56 times higher), a predicted length of stay increase of 62.22%, and the highest total hospitalization costs ($79,613), highlighting the need for improved patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implications of hospital acquired adverse events on mortality, length of stay and costs for patients undergoing radical cystectomy for bladder cancer. Kim, SP., Shah, ND., Karnes, RJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cystoscopy and Systematic Bladder Tissue Sampling in Predicting pT0 Bladder Cancer: A Prospective Trial. [2022]

2. Iran pubmed.ncbi.nlm.nih.gov

Risk factors for disconcordance between pre and post radical cystectomy stages. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Extent of surgery and pathology evaluation has an impact on bladder cancer outcomes after radical cystectomy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Reducing Overutilization of Preoperative Medical Referrals Among Patients Undergoing Radical Cystectomy Using an Evidence-based Algorithm. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative optimization of the radical cystectomy patient: Current state and future directions. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radical cystectomy is safe in elderly patients at high risk. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

The implications of hospital acquired adverse events on mortality, length of stay and costs for patients undergoing radical cystectomy for bladder cancer. [2022]

9. Japan pubmed.ncbi.nlm.nih.gov

[Retrospetive analysis of early postoperative complications of radical cystectomy and urinary diversion performed during a 17-year period]. [2010]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Complications for radical cystectomy. Impact of the American Society of Anesthesiologists score. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Predictors of postoperative outcomes of cubital tunnel syndrome treatments using multiple logistic regression analysis. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Application of ulnar nerve diameter changes examined by HRUS in patients with cubital tunnel syndrome]. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Ultrasound in the diagnosis of ulnar neuropathy at the cubital tunnel. [2022]

14. Turkey pubmed.ncbi.nlm.nih.gov

Decision Making via 3D Computed Tomography in the Surgical Treatment of Cubital Tunnel Syndrome: Surgical Technique and Results. [2022]

15. Germany pubmed.ncbi.nlm.nih.gov

Decompression without anterior transposition: an effective minimally invasive technique for cubital tunnel syndrome. [2014]