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New treatment option for Urothelial Carcinoma Bladder
Official title Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
ClinicalTrials.gov ID: NCT06184516
What this study is testing
- What it's testing
- Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression.
- Phase 2: a mid-size study of how well it works
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 99, women only
You may be able to join if
- Female ≥ eighteen years of age
- Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
- Surgical candidate for radical cystectomy
- Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:
- MRI of the pelvis on 1.5T or higher strength magnet.
You likely can't join if
- Patients with regional or distant metastatic disease
- Non-urothelial bladder cancer.
- Not a surgical candidate for radical cystectomy
- Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
- people of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for...
- Patients with other known active malignancies which may confound the recurrence rates
See the full eligibility criteria
- Female ≥ eighteen years of age
- Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
- Surgical candidate for radical cystectomy
- Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:
- MRI of the pelvis on 1.5T or higher strength magnet.
- T2 weighted imaging in multiple planes.
- T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency)
- Cystoscopic evaluation completed by urologist within 120 days prior to surgery (ROS-RC or RC)
- Staging imaging within 90 days prior to surgery (ROS-RC or RC). If receiving neoadjuvant therapy prior to surgery (ROS-RC or RC), repeat staging imaging must be completed after the neoadjuvant therapy is completed, or...
- Staging imaging must include MRI of the pelvis within 90 days of surgery (ROS-RC or RC)
- Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
- Presence of at least one or more ancillary organs. Ancillary organs defined as anterior vagina, uterus, fallopian tubes (only 1 tube present will be considered at physician discretion), and ovaries.
- ECOG Performance Status of 0-2
- Patients with regional or distant metastatic disease
- Non-urothelial bladder cancer.
- Not a surgical candidate for radical cystectomy
- Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
- people of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.
- Patients with other known active malignancies which may confound the recurrence rates
- Patients with known germline mutations in DNA damage repair genes (BRCA1/BRCA 2)
- Prisoners or people who are involuntarily incarcerated.
- people who are compulsorily detained for treatment of either a psychiatric or physical illness.
- people demonstrating an inability to comply with the study and/or follow-up procedures.
- people who are confirmed to be pregnant or breastfeeding.
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or...
- Administration of a vaccine containing live virus within 30 days prior to the study intervention. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
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 female, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. 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.