Urothelial Carcinoma Clinical Trial
Official title:
A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Upper tract urothelial carcinoma (UTUC) diagnosis include urography using computed tomography urography (CTU) or urography using MRI (MRU). The sensitivity of CTU decreases substan¬tially with decreasing lesion size. Other drawbacks of CTU include the radiation exposure and potential adverse effects in patients with allergic reactions or pre-existing renal impairment. In terms of urine cytology, the major drawbacks of urine cytology are low sensitivity and highly dependent of the experience and skills of the cytopathologist. We here intended to investigate whether UroCAD can be added in the diagnostic work-up of UTUC patient, and improve the accuracy of predicting UTUC before surgery.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 30, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients suspected with UTUC and planned to undergo surgery such as such ureteroscopy or radical nephroureterectomy. Participants without any tumor disease and willing to attend the study by providing morning urine. Male or female patients aged >= 18 years. Participants signed informed consent form. Exclusion Criteria: Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record. Patient already received suprapubic cystostomy or urethral catheterization. Participants with late-stage uremia and need regular dialysis. Participants with reasons like elevated serum creatinine, allergy to intravenous CT contrast media et al, and unable to undergo CTU. Patient with cancer other than urothelial carcinoma. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Baard J, de Bruin DM, Zondervan PJ, Kamphuis G, de la Rosette J, Laguna MP. Diagnostic dilemmas in patients with upper tract urothelial carcinoma. Nat Rev Urol. 2017 Mar;14(3):181-191. doi: 10.1038/nrurol.2016.252. Epub 2016 Dec 13. Review. — View Citation
Janisch F, Shariat SF, Baltzer P, Fajkovic H, Kimura S, Iwata T, Korn P, Yang L, Glybochko PV, Rink M, Abufaraj M. Diagnostic performance of multidetector computed tomographic (MDCTU) in upper tract urothelial carcinoma (UTUC): a systematic review and meta-analysis. World J Urol. 2020 May;38(5):1165-1175. doi: 10.1007/s00345-019-02875-8. Epub 2019 Jul 18. — View Citation
Zeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology | Number of patients "declared positive" with the UroCAD assay, CTU or cytology among the patients suffered from UTUC and number of patients "declared negative" with these tests among the patients without cancer. | Through study completion, an average of 30 months | |
Secondary | Identification of the correlation between the level of CNV and the grade of the tumor sample | Level of CNV in the urine sample compared with the grade of the tumor confirmed by histopathologic examination | Through study completion, an average of 30 months | |
Secondary | Identification of the correlation between the level of CNV and the stage of the tumor sample | Level of CNV in the urine sample compared with the stage of the tumor confirmed by histopathologic examination | Through study completion, an average of 30 months | |
Secondary | Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology and CTU | Number of patients "declared positive" with the UroCAD analysis versus patients "declared positive" with the urine cytology or CTU, and number of patients "declared negative" with the UroCAD analysis versus patients " declared negative " with the urine cytology or CTU. | Through study completion, an average of 30 months |
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