Gainesville, FLNCT06184516Now EnrollingIRB Ready

Urothelial Carcinoma Bladder Clinical Trial in Gainesville, FL

Access cutting-edge urothelial carcinoma bladder treatment through this clinical trial at a research site in Gainesville. Study-provided care at no cost to qualified participants.

Sponsored by University of Florida

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Expert Care in Gainesville

Access urothelial carcinoma bladder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related urothelial carcinoma bladder treatment provided free

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Check if you qualify for this urothelial carcinoma bladder clinical trial in Gainesville, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Gainesville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Gainesville site if eligible
  4. 4Begin participation

About This Urothelial Carcinoma Bladder Study in Gainesville

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. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.

Sponsor: University of Florida

Who Can Participate

Inclusion 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 no longer tolerated by the patient.
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

Exclusion Criteria

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.
Subjects 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 subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
Subjects 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 that might affect the interpretation of the results of the study or that puts the subject at high risk for complications, in the opinion of the treating physician.
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 attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT06184516) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Urothelial Carcinoma Bladder Treatment Options in Gainesville, FL

If you're searching for urothelial carcinoma bladder treatment options in Gainesville, FL, this clinical trial (NCT06184516) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced urothelial carcinoma bladder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all urothelial carcinoma bladder clinical trials near you to find additional studies recruiting in your area.

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