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NCT03757949 · ClinicalTrials.gov registry record · Phase 3
Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
A Phase 3 study of Bladder Carcinoma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
- 20
- Study locations
NCT03757949: Active Phase 3 study of Bladder Carcinoma, sponsored by SWOG Cancer Research Network.
NCT03757949 is a Phase 3 study of Bladder Carcinoma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 203 participants, below the 3,529-participant average among 10 other Bladder Carcinoma trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03757949, a Phase 3 study of Bladder Carcinoma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
Primary Outcome
A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none);
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DIETARY_SUPPLEMENT Nutritional Intervention
- OTHER Placebo Administration
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- Keck Medical Center of USC Pasadena - Pasadena
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Illinois
- Northwestern University - Chicago
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Decatur Memorial Hospital - Decatur
Michigan
- Saint Joseph Mercy Hospital - Ann Arbor
- IHA Hematology Oncology Consultants-Brighton - Brighton
- Saint Joseph Mercy Brighton - Brighton
Maine
- Maine Medical Center-Bramhall Campus - Portland
- Maine Medical Center- Scarborough Campus - Scarborough
Colorado
- University of Colorado Hospital - Aurora
Florida
- Mayo Clinic in Florida - Jacksonville
Louisiana
- LSU Healthcare Network / Metairie Multi-Specialty Clinic - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2019-03-05 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 3 |
What the registry record for NCT03757949 still lists
NCT03757949 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 3,529-participant average among 10 other Bladder Carcinoma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Bladder Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03757949 names 20 study sites across 8 states, led by California, Kansas, Illinois.
Frequently Asked Questions
What is clinical trial NCT03757949 about?
NCT03757949 is a clinical study titled "Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery". This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
What is the current status of trial NCT03757949?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2019-03-05. Estimated completion is 2027-01-01.
What conditions does trial NCT03757949 study?
This clinical trial studies the following conditions: Bladder Carcinoma.
What interventions are being tested in trial NCT03757949?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Nutritional Intervention (DIETARY_SUPPLEMENT), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT03757949?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03757949 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03757949's enrollment target sits among peer trials
203 7th of 10 higher than 4 of 10 other Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Carcinoma 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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