Trial · NCT06919965
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-free Survival (DFS) | Up to 5 years | DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first. |
| Secondary | Recurrence-Free Survival (RFS) | Up to 5 years | RFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1, or CIS), or death due to any cause, whichever occurs first. |
| Secondary | Time to Next Intervention (TTNI) | Up to 5 years | TTNI (i.e., transurethral resection of bladder tumor \[TURBT\], radical cystectomy \[RC\], radiation therapy \[RT\], or chemotherapy) is measured as the time from randomization to the date of next intervention (localized or systemic) for the treatment of urothelial carcinoma (UC). |
| Secondary | Time to Disease Worsening (TTDW) | Up to 5 years | TTDW is measured as the time from randomization to the date of cystectomy, systemic therapy, or radiation therapy, whichever occurs first. |
| Secondary | Time to Progression (TTP) | Up to 5 years | TTP is measured as the time from randomization to the date of first documented evidence of disease progression (i.e., progression to muscle-invasive bladder cancer \[MIBC\] \[T greater than or equal to {\>=} 2\], lymph node \[N+\], or distant disease \[M+\]), or death due to disease progression, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 5 years | OS is defined as the time from randomization to death due to any cause. |
| Secondary | Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Up to 5 years | Number of participants with AEs by severity grade as assessed by CTCAE version 5.0 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event. |
| Secondary | Number of Participants With Change from Baseline in Laboratory Abnormalities | Up to 5 years | Number of participants with change from baseline in laboratory abnormalities (hematology, serum chemistry and urine analysis) will be reported. |
| Secondary | Number of Participants With Change from Baseline in Vital Signs Abnormalities | Up to 5 years | Number of participants with change from baseline in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported. |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96 | EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms. |
| Secondary | Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores | Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96 | EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning. |
| Secondary | Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores | Weeks 12, 24, 36, 48, 60, 72, 84 and 96 | EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms. |
| Secondary | Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores | Weeks 12, 24, 36, 48, 60, 72, 84 and 96 | EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning. |
| Secondary | Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168) | Up to Week 96 | EORTC Q168 is a single item from the EORTC item library used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates greater impact. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06919965/registered