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

September 5, 2021 updated by: Shuxiong Zeng, Changhai Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The recommendations for imaging in UTUC diagnosis include urography using CTU or MRU. In the standard diag¬nostic work up, urine cytology and a cystoscopy to rule out a concomitant bladder tumor are also advised. In addition, diagnostic ureterorenoscopy and biopsy are advised in patients in whom the findings of these pro¬cedures could influence treatment decisions, The sensitivity of CTU decreases substan¬tially with decreasing lesion size. For polypoid tumors of 5-10 mm maximal diameter, CTU has a high sensitivity and specificity, but sensitivity decreases to 89% for lesions <5 mm and further to 40% for lesions <3 mm. Flat lesions are even more difficult to diagnose. Other drawbacks of CTU include the radiation exposure and the need for intravenous contrast media with accompa¬nying potential adverse effects in patients with allergic reactions or pre-existing renal impairment. In terms of urine cytology, the major drawbacks of urine cytology tests: the sensitivity of positive urine cytology is highly dependent on tumor grade and decreases to 12% for low-grade tumors and 15% for non-invasive stage Ta tumors. Hence, low-grade urothelial tumors cannot be reliably detected by urine cytology. Finally, the accuracy of the cytology findings is highly dependent of the experience and skills of the cytopathologist. Our previous study has proved that UroCAD, which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential role in diagnosis of UTUC in combination with CTU and cytology hasn't been assessed yet and the accuracy of UroCAD in detecting UTUC still need to be further validated. 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.

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology
Time Frame: Through study completion, an average of 30 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the correlation between the level of CNV and the grade of the tumor sample
Time Frame: Through study completion, an average of 30 months
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
Identification of the correlation between the level of CNV and the stage of the tumor sample
Time Frame: Through study completion, an average of 30 months
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
Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology and CTU
Time Frame: Through study completion, an average of 30 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Director: Chuangliang Xu, M.D., Ph.D, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

September 5, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (ACTUAL)

September 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 5, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UroCAD-UTUC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To pretect the personal privacy of participants and the genetic sequencing information, IPD data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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