Urothelial CarcinomaNCT05043662
UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
An observational study of Urothelial Carcinoma and Diagnoses Disease, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Diagnoses Disease, Ureter Cancer
- What is being tested?
- UroCAD assay, CTU examination and urine cytology
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients suspected of UTUC or participants in control group from September 2021 to October 2022 in Changhai hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Shuxiong Zeng, M.D. Ph.D, +8618930568759, zengshuxiong@126.com
About this study
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.
Read the 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.
- Conditions
- Urothelial Carcinoma, Diagnoses Disease, Ureter Cancer, IMAGE, Cytology
- Being tested
- UroCAD assay, CTU examination and urine cytology
- Keywords
- UTUC, CIN, cytology, CTU
- Medical subject headings
- Carcinoma, Transitional Cell, Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroCAD assay, CTU examination and urine cytologyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: UroCAD assay, CTU examination and urine cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Level of CNV in the urine sample compared with the grade of the tumor confirmed by histopathologic examination
Measured: Through study completion, an average of 30 months
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
Measured: Through study completion, an average of 30 months
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.
Measured: Through study completion, an average of 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxiong Zeng, Changhai Hospital
- Investigators
- Chuangliang Xu, M.D., Ph.D, Study director, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043662
- Sponsor's protocol ID
- UroCAD-UTUC
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To pretect the personal privacy of participants and the genetic sequencing information, IPD data will not be shared.
Publications
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.
PubMed 27958391Janisch 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.
PubMed 31321509Zeng 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.
PubMed 33037018Yang G, Zeng S, He W, Zhang L, Xu C, Pan J, Xue W. Clinical validation of UroCAD test for upper tract urothelial carcinoma detection: results from a prospective multi-center study. J Hematol Oncol. 2026 Jan 9;19(1):8. doi: 10.1186/s13045-025-01772-5.
PubMed 41508041
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
- ClinicalTrials.gov ID
- NCT05043662
- Acronym / sponsor ID
- UroCAD-UTUC
- Conditions
- Urothelial Carcinoma, Diagnoses Disease, Ureter Cancer, IMAGE, Cytology
- Keywords
- UTUC, CIN, cytology, CTU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urothelial carcinoma group | – | Diagnostic Test: UroCAD assay, CTU examination and urine cytologyThe 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). |
| Control group | – | Diagnostic Test: UroCAD assay, CTU examination and urine cytologyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of UTUC or participants in control group from September 2021 to October 2022 in Changhai hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroCAD assay, CTU examination and urine cytologyThe 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. | Diagnostic test | Control group, Urothelial carcinoma group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 27958391Baard 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.
- Background: PubMed 31321509Janisch 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.
- Results publication: PubMed 33037018Zeng 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.
- Derived from this study: PubMed 41508041Yang G, Zeng S, He W, Zhang L, Xu C, Pan J, Xue W. Clinical validation of UroCAD test for upper tract urothelial carcinoma detection: results from a prospective multi-center study. J Hematol Oncol. 2026 Jan 9;19(1):8. doi: 10.1186/s13045-025-01772-5.
- Individual participant dataSharing planned: No. To pretect the personal privacy of participants and the genetic sequencing information, IPD data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuangliang Xu, M.D., Ph.D study director
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma and Diagnoses Disease, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuxiong Zeng, M.D., Ph.D (86-021-31161718, zengshuxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology (time frame: Through study completion, an average of 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043662, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.