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Vascularized Composite Allograft
Robotic Bladder Transplant for Bladder Cancer
N/A
Recruiting
Led By Inderbir Gill
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65 years
Patients on pre-existing immunosuppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year within 7 days post-transplantation
Awards & highlights
Study Summary
This trial is testing whether a robotic transplant of a vascularized composite bladder allograft is feasible, functional, and sustainable in treating patients with bladder cancer.
Who is the study for?
This trial is for adults aged 18-65 with severe bladder issues needing a radical cystectomy, already on immunosuppression or will be soon. They must be able to perform self-catheterization and commit to the treatment plan. Excluded are those with HIV/AIDS, active hepatitis B/C, certain infections, poor medical compliance, substance abuse issues, recent non-urothelial malignancy history or without need for future immunosuppression.Check my eligibility
What is being tested?
The study tests robotic vascularized composite bladder allograft transplantation as an alternative to standard urinary diversion in patients with terminal bladder pathology. It aims to assess if this new method is feasible and sustainable compared to traditional techniques using bowel tissue.See study design
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection or bleeding; adverse reactions from long-term immunosuppression like increased risk of infections and possibly organ rejection; manual dexterity challenges due to catheterizations post-surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I am currently on medication to suppress my immune system.
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My blood type matches the donor's.
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I am between 18 and 65 years old.
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As a donor, I don't need strong medication to keep my blood pressure normal.
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I have had bladder problems leading to frequent infections or kidney issues.
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I have bladder cancer that has not spread and needs surgery, and I am on or will need immunosuppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 7, 30, 90, 180, and 360 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 7, 30, 90, 180, and 360 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Technical success of vascularized composite bladder allograft (VCBA) transplantation
Secondary outcome measures
Adverse events associated with VCBA transplantation
Bladder function
Transplant rejection
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (VCBA)Experimental Treatment2 Interventions
Patients undergo robotic VCBA transplantation.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,283 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,127 Total Patients Enrolled
Inderbir GillPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am committed to following the treatment plan as directed.I have had surgery on my bladder or prostate.I have an abnormal bladder capacity.The donor has tested positive for Hepatitis C virus (HCV) antibodies or has a detectable viral load.I am between 18 and 65 years old.I am currently on medication to suppress my immune system.My blood type matches the donor's.I am between 18 and 65 years old.I don't have any health conditions that could interfere with the treatment.Your blood does not match with the donor's blood.I do not have an active sexually transmitted disease.The donor and recipient must not have any compatibility issues in their blood.My body is less likely to reject a transplant, with low immune response to the donor.As a donor, I don't need strong medication to keep my blood pressure normal.I have bladder cancer that has not spread and needs surgery, and I am on or will need immunosuppression.I have had bladder problems leading to frequent infections or kidney issues.I am a donor without current sepsis.I have not had any cancer other than bladder cancer, or any cancer spread, in the last 5 years.I, as a donor, do not have active CMV, EBV, or TB infections.I am a donor and I have tested positive for hepatitis B.You are unable to get the necessary medical care or medication due to where you live, money, or other reasons.You need to be able to use a catheter on your own or have someone who can help you at home.I do not have active infections like HIV, hepatitis B or C, or tuberculosis.I do not have conditions like severe blood disorders or liver problems that could affect surgery.I have quit smoking for at least 6 months and plan to not smoke after surgery.I, as a donor, have a history of bladder or prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (VCBA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants enlisted in this clinical investigation?
"Indeed, the information posted on clinicaltrials.gov demonstrates that this medical study has opened its recruitment process. Initially listed on October 3rd 2022, it was last modified on November 12th 2022 and is now looking for 5 volunteers across 1 site."
Answered by AI
Is this research endeavor accessible to those who are interested in participating?
"Yes, according to the clinicaltrial.gov website, this study is actively recruiting participants. The trial was first published on October 3rd 2022 and last updated November 12th 2022 and it aims to enroll 5 individuals at a single site."
Answered by AI
Would I be an eligible participant in this clinical investigation?
"This trial is looking to recruit 5 individuals, aged between 18 and 65, with urinary bladder cancer. To be considered for the study, candidates must meet stringent criteria such as: age range of 18-65 years; hydronephrosis resulting in kidney disease due to poor compliance from bladder pathology; localized non-metastatic muscle invasive (cT2 or T3) bladder cancer requiring radical cystectomy; less than 30% of accrued patients predicted to have bladder cancer as their etiology; on immunosuppression for pre-existing solid organ transplantation with consenting dedication to the immunomodulatory treatment regime ; appropriate"
Answered by AI
Are individuals aged 65 and above allowed to partake in this research?
"This trial is open to participants who are of legal age and under 65 years old."
Answered by AI
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