| Autor: |
Schroeck FR; White River Junction VA Medical Center, White River Junction, VT, USA.; Section of Urology, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.; Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.; The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, Lebanon, NH, USA., Grubb R; Department of Urology, Medical University of South Carolina, Charleston, SC, USA., MacKenzie TA; The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, Lebanon, NH, USA.; Department of Biomedical Data Science, Dartmouth College, Lebanon, NH, USA., Ould Ismail AA; White River Junction VA Medical Center, White River Junction, VT, USA., Jensen L; White River Junction VA Medical Center, White River Junction, VT, USA., Tsongalis GJ; Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Lotan Y; Department of Urology, University of Texas Southwestern, Dallas, TX, USA. |
| Abstrakt: |
"Replace Cysto" is a multisite randomized phase 2 trial including 240 participants with low-grade intermediate-risk non-muscle-invasive bladder cancer, in which participants will be randomized 1:1:1 to one of two urine marker-based approaches alternating a urine marker test (Xpert Bladder Cancer Monitor or Bladder EpiCheck) with cystoscopy or to frequent scheduled cystoscopy. The primary objective is to determine whether urinary quality of life after surveillance is significantly improved in the urine marker arms. The primary outcome will be the patient-reported urinary quality of life domain score of the validated QLQ-NMIBC24 instrument, measured 1-3 d after surveillance. Exploratory outcomes include discomfort after surveillance, the number of invasive procedures that participants undergo per 1000 person years, complications from these procedures per 1000 person years, nonurinary quality of life, acceptability of surveillance, and bladder cancer recurrence and progression. Comparators include surveillance using (1) the Xpert Bladder Cancer Monitor test, (2) the Bladder EpiCheck urinary marker, or (3) frequent cystoscopy alone. After a negative cystoscopy ≤4 mo following bladder tumor resection, all the participants will undergo surveillance at 6, 12, 18, and 24 mo (with time zero defined as the date of the most recent bladder tumor resection). In the urine marker arms, surveillance at 6 and 18 mo will be performed with the marker. Regardless of the arm, participants will undergo cystoscopy at 12 and 24 mo. End of study for each participant will be their 24-mo cystoscopy. Overall trial duration is estimated at 5 yr from when the study opens to enrollment until completion of data analyses. The trial is registered at clinicaltrials.gov (NCT05796375). |
