Urinary Bladder CancerNCT05335707
Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy
An observational study of Urinary Bladder Cancer, run by University of Kansas Medical Center.
Trial summary
This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Bladder Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2022to 21 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 and older with biopsy-proven muscle-invasive bladder cancer planned for neoadjuvant chemotherapy and radical cystectomy.
Who may be able to join
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 65 years
- Diagnosis/disease status
- Histologically proven muscle-invasive bladder cancer (MIBC) without metastatic disease.
- Patients planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC.
- Treatment with investigational systemic therapy is permitted if participants will be receiving chemotherapy as part of their treatment plan
Who cannot join
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Any other known invasive malignancy within previous 2 years with the following EXCEPT: low grade prostate cancer on active surveillance, chronic lymphocytic leukemia CLL on surveillance / observation, non-melanoma skin cancers
About this study
Official title: Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy: A Pilot Trial
This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy.
- Conditions
- Urinary Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a geriatric oncology assessment clinic and workflows
Develop a geriatric oncology assessment clinic and workflows for the University of Kansas Health System, including University of Kansas Cancer Center St. Francis and Great Bend practices.
Measured: 12 months
Secondary outcomes (1)
Test feasibility, acceptability, and preliminary impact
Test feasibility, acceptability, and preliminary impact of the Comprehensive Geriatric Assessment (CGA) and CGA-directed care.
Note: The results of the CGA will be used by clinicians to guide patients' medical care.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start14 Sep 2022
- Primary completion11 Aug 2023
- Study completion21 Aug 2023
Why it stopped: Study funds ended on 7/31/2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Wulff-Burchfield, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335707
- Sponsor's protocol ID
- IIT-2021-GerioncBladder
- Status last verified
- Feb 2024
- First submitted
- 12 Apr 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05335707
- Acronym / sponsor ID
- IIT-2021-GerioncBladder
- Conditions
- Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study funds ended on 7/31/2023
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 and older with biopsy-proven muscle-invasive bladder cancer planned for neoadjuvant chemotherapy and radical cystectomy.
Key inclusion criteria (6 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 65 years
- Diagnosis/disease status
- Histologically proven muscle-invasive bladder cancer (MIBC) without metastatic disease.
- Patients planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC.
Key exclusion criteria (2 listed)
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Any other known invasive malignancy within previous 2 years with the following EXCEPT: low grade prostate cancer on active surveillance, chronic lymphocytic leukemia CLL on surveillance / observation, non-melanoma skin cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a geriatric oncology assessment clinic and workflows
Time frame: 12 months
Develop a geriatric oncology assessment clinic and workflows for the University of Kansas Health System, including University of Kansas Cancer Center St. Francis and Great Bend practices.
1 secondary outcome
Test feasibility, acceptability, and preliminary impact
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Urinary Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Cancer, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a geriatric oncology assessment clinic and workflows (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.