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NCT06138561 · ClinicalTrials.gov registry record
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
A clinical trial of Bladder Cancer and Urothelial Carcinoma, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- 180
- Enrollment target
- 1
- Study location
NCT06138561: Recruiting study of Bladder Cancer and Urothelial Carcinoma, sponsored by Dana-Farber Cancer Institute.
NCT06138561 is a study of Bladder Cancer and Urothelial Carcinoma that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 180 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06138561, a study of Bladder Cancer and Urothelial Carcinoma, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants undergoing cancer treatments. Additionally, investigators are evaluating the differential impact of treatments on quality of life in an older and at risk population.
Primary Outcome
In frail and at-risk patients, as defined by geriatric-8 scores, will evaluate the difference in quality of life for participants receiving Carboplatin-based chemotherapy followed by immunotherapy maintenance versus Enfortumab Vedotin-Pembrolizumab. Quality of life will be measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (NFBISI-18) version 2 questionnaire, a patient reported, eighteen question measure graded on a Likert scale
Conditions Studied
Interventions
- BEHAVIORAL Geriatric-8 Survey
- BEHAVIORAL National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18)
- BEHAVIORAL Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2028-01-01 |
What NCT06138561 shows while recruiting
NCT06138561 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Geriatric-8 Survey is the first listed.
NCT06138561 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06138561 about?
NCT06138561 is a clinical study titled "Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments". The goal of this study is to better understand how to best treat participants with advanced bladder cancer who may not be able to tolerate all of the chemotherapy drugs that have been shown to be effective. In this study, investigators are assessing the role of the survey, the Geriatric-8, and its a...
What is the current status of trial NCT06138561?
This trial is currently recruiting. The enrollment target is 180 participants. The study started on 2024-03-05. Estimated completion is 2028-01-01.
What conditions does trial NCT06138561 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Carcinoma, Metastatic Bladder Cancer, Unresectable Bladder Carcinoma.
What interventions are being tested in trial NCT06138561?
The interventions under investigation include: Geriatric-8 Survey (BEHAVIORAL), National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Bladder Symptom Index-18 (FBISI-18) (BEHAVIORAL), Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06138561?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06138561 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06138561's enrollment target sits among peer trials
180 62nd of 175 higher than 114 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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