Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT06138561
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2023-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Management of Cisplatin-Ineligible Patients With Metastatic Bladder Cancer and The Role of Geriatric Assessments
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
In this prospective, observational study, investigators are assessing the optimal approach to treating bladder cancer in older participants with other disease that might put the participants at additional risk from cancer-directed treatments. Investigators are specifically assessing the impact on adverse events, quality of life, and treatment outcomes. Additionally, investigators are assessing the role of the survey, the Geriatric-8, and its ability to predict outcomes in older participants.
The research study procedures include screening for eligibility and completing questionnaires.
Participation in this research study is expected to last for up to 8 months.
It is expected that about 180 people will take part in this research study.
The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.
The research study procedures include screening for eligibility and completing questionnaires.
Participation in this research study is expected to last for up to 8 months.
It is expected that about 180 people will take part in this research study.
The National Comprehensive Cancer Network and EMD Serono are supporting this research study by providing the necessary funds.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: