BOBÌåÓý

Skip to main content

Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    Female
  • Healthy Volunteers
    No
I'm interested
Share this study

Objective

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.

Details

Full study title Assessing the Pathologic Outcomes of a Decision Tool to Select Women with Bladder Cancer for Reproductive Organ Sparing Radical Cystectomy
Protocol number OCR44653
ClinicalTrials.gov ID NCT06184516
Phase Phase 2

Eligibility

Inclusion Criteria:

  • Female â‰� 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.

Lead researcher

  • Surgical Oncologist (Surgical Specialist - Cancer), Urologist

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.