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

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05043662
Collaborator
(none)
110
Enrollment
1
Location
15.9
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: UroCAD assay, CTU examination and urine cytology

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 Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology [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.

Secondary Outcome Measures

  1. Identification of the correlation between the level of CNV and the grade of the tumor sample [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

  2. Identification of the correlation between the level of CNV and the stage of the tumor sample [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

  3. Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology and CTU [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Changhai HospitalShanghaiShanghaiChina200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shuxiong Zeng, M.D., Ph.D, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05043662
Other Study ID Numbers:
  • UroCAD-UTUC
First Posted:
Sep 14, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shuxiong Zeng, M.D., Ph.D, Changhai Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021