UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.

NCT05043662 | Unknown

• 1 other identifier: UroCAD-UTUC
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urothelial Carcinoma; Diagnoses Disease; Ureter Cancer; IMAGE; Cytology

Keywords

UTUC; CIN; cytology; CTU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Identification of the correlation between the level of CNV and the grade of the tumor sample

  Through study completion, an average of 30 months

• Identification of the correlation between the level of CNV and the stage of the tumor sample

  Through study completion, an average of 30 months

• Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology and CTU

  Through study completion, an average of 30 months

Study Arms (2)

Urothelial carcinoma group

The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. CTU and cytology will be performed according to the routine of clinical practice (N=80).

Diagnostic Test: UroCAD assay, CTU examination and urine cytology

Control group

Patients need to undergo CTU examination and being treated for benign diseases with ureteroscopy, but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of UroCAD, CTU and cytology assay (N=30).

Diagnostic Test: UroCAD assay, CTU examination and urine cytology

Interventions

UroCAD assay, CTU examination and urine cytology DIAGNOSTIC_TEST

The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. CTU and cytology will be performed according to the routine of clinical practice.

Control group; Urothelial carcinoma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of UTUC or participants in control group from September 2021 to October 2022 in Changhai hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 27958391 BACKGROUND

• 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.

  PMID: 31321509 BACKGROUND

• 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. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9.

  PMID: 33037018 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The extracted DNA from morning urine

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Ureteral Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ureteral Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chuangliang Xu, M.D., Ph.D

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Shuxiong Zeng, M.D., Ph.D

CONTACT

86-021-31161718; zengshuxiong@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)