A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up
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ClinicalTrials.gov Identifier: NCT04432909 |
Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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Condition or disease | Intervention/treatment |
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Urothelial Carcinoma | Diagnostic Test: The level of CNV |
The traditional diagnostic methods of UC include CT urography (CTU) and cystoscopy. To access the upper urinary tract, CTU is commonly used. The sensitivity for detecting upper tract urothelial cancer with CTU has been reported to reach 89%. However, the specificity of CTU is 51% and it cannot get a biopsy sample. Other shortcomings include exposing the patient to high dose of radiation and the contrast material usage may impair the renal function. In the context of diagnosing lower urinary tract cancer, cystoscopy is the "gold standard" diagnostic procedure, which has a sensitivity of 68-83%. But it is invasive, uncomfortable and may miss flat lesions. Furthermore, due to the high recurrence rate of bladder cancer, surveillance of the disease with frequent cystoscopy make it one of the costliest cancers. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed.
Copy number variations (CNVs) refers to the ongoing acquisition of genomic alterations ranging from point mutations to gross chromosomal rearrangements, is a hallmark of cancer which is found in 60-80% of human cancer, and it positively correlates with high tumor stage, poor prognosis, metastasis and therapeutic resistance. Several researches have investigated the value of detecting chromosomal instability with sWGS in either cell-free (cf)DNA or genomic DNA as a noninvasive diagnostic method for cancers and yielded quite fine results. Our previous research has also proved the UroCAD model reached performance of AUC=0.928, with sensitivity, specificity and accuracy of 82.5%, 96.9% and 89.0%, respectively. This test also showed superiority in diagnosing upper tract urothelial cancer compared with urinary cytology test.
Here we intended to conduct a prospective, multicenter, single-blinded research to further validate the value of UroCAD in diagnosing UC and investigate the potential of UroCAD in UC patient follow-up by analyzing the CNV level of patient DNA extracted from urine exfoliated cells and follow UC patient for up to 2 years to determine if there is a correlation between CNV level and patient prognosis. Patient information, which is acquired every 3 months after surgery, including survival status, CNV level in urine exfoliated cells, treatment during this period, medical examination during this period, etc.
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up |
Actual Study Start Date : | January 17, 2020 |
Estimated Primary Completion Date : | January 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |

Group/Cohort | Intervention/treatment |
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Urothelial carcinoma group
Pre-surgery patients with urothelial carcinoma will be the experimental group to determine the sensitivity and specificity of UroCAD analysis, the result will be compared with cytology and FISH test.
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Diagnostic Test: The level of CNV
The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. And the patient will be followed for up to 2 years.
Other Name: UroCAD test of the urine exfoliated cells |
Non-cancer participants
Patients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of UroCAD analysis.
|
Diagnostic Test: The level of CNV
The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. And the patient will be followed for up to 2 years.
Other Name: UroCAD test of the urine exfoliated cells |
- Sensitivity and Specificity of urinalysis by UroCAD analysis [ Time Frame: through study completion, an average of 30 months ]number of patients "declared positive" with the UroCAD test among the patients suffered from urothelial carcinoma and number of patients "declared negative" with the UCAD test among the patients without cancer.
- Assess the value of UroCAD for urothelial cancer patient follow-up [ Time Frame: through study completion, an average of 30 months ]Compare the CNV level with the patient information gathered by follow-up to determine whether there is a correlation between CNV level and patient prognosis or disease progression
- 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
- 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
- Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology [ 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 and number of patients "declared negative" with the UroCAD analysis versus patients " declared negative " with the urine cytology
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients diagnosed with urothelial carcinoma and planned to undergo surgery
- Cancer patient with urine cytology test result
- Cancer patient willing to provide urine sample before the surgery, 3 months after surgery, 6 months after surgery, 12 month after surgery, 15 months after surgery, 18 months after surgery, 21 months after surgery, 24 months after surgery, and willing to provide patient information.
- 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:
- Age under 18 years
- 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.
- Patient with late-stage uremia and need regular dialysis.
- Patient with cancer other than urothelial carcinoma.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432909
Contact: Shuxiong Zeng, M.D., Ph.D. | +8618930568759 | zengshuxiong@126.com |
China, Shanghai | |
Changhai Hospital | Recruiting |
Shanghai, Shanghai, China, 200433 | |
Contact: Shuxiong Zeng, M.D. Ph.D +8618930568759 zengshuxiong@126.com |
Study Chair: | Chuanliang Xu, M.D.,Ph.D. | Changhai Hospital, Shanghai |
Responsible Party: | Shuxiong Zeng, Ph.D, M.D., Changhai Hospital |
ClinicalTrials.gov Identifier: | NCT04432909 |
Other Study ID Numbers: |
CH-urothelial-cancer-marker |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We will try to protect the information of the included participants |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
diagnosis follow-up |
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |