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Updated: Jun 16, 2026

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Patient-derived Orthotopic Xenograft Models for Human Urothelial Cell Carcinoma and Colorectal Cancer Tumor Growth and Spontaneous Metastasis
Published on: May 12, 2019
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Development and Multicenter Case-Control Validation of Urinary Comprehensive Genomic Profiling for Urothelial
Keyan Salari1,2,3, Debasish Sundi4, Jason J Lee1
1Department of Urology, Massachusetts General Hospital, Boston, Massachusetts.
Summary
Urinary comprehensive genomic profiling (uCGP) offers a noninvasive method for diagnosing urothelial carcinoma and assessing recurrence risk. This genomic test shows high accuracy in identifying cancer and predicting patient outcomes.
Area of Science:
- Oncology
- Genomics
- Urology
Background:
- Urothelial carcinoma diagnosis relies on invasive methods.
- Accurate risk stratification and recurrence prediction are crucial for patient management.
Purpose of the Study:
- To evaluate the efficacy of urinary comprehensive genomic profiling (uCGP) for noninvasive urothelial carcinoma detection and risk stratification.
- To compare uCGP performance against traditional diagnostic methods like cytology and cystoscopy.
Main Methods:
- A multicenter case-control study analyzed 581 urine specimens using the UroAmp platform for uCGP.
- Next-generation sequencing identified various mutation classes.
- Algorithms were developed for tumor presence, grade, and recurrence risk prediction, then validated.
Main Results:
- uCGP achieved 95% sensitivity and 90% specificity for initial cancer diagnosis in hematuria patients, with a 99% negative predictive value.
- Recurrence risk prediction by uCGP was a significant prognostic factor (hazard ratio, 6.2).
- Molecular grade prediction showed 88% positive predictive value and 95% specificity.
Conclusions:
- uCGP provides a noninvasive and accurate method for diagnosing urothelial carcinoma.
- The technology enables effective risk stratification for patients with hematuria and those undergoing surveillance.

