HematuriaNCT05893316
UroCAD for Hematuria Evaluation--A Prospective, Multi-center Study
An observational study of Hematuria and Urothelial Carcinoma, run by Changhai Hospital at 1 site in China.
Trial summary
Hematuria is recognized as an important sigh of potential urinary tract malignancy. Therefore, understanding the disease processes and discovering the potential urothelial carcinoma (UC) underlying this important sign is critical. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematuria, Urothelial Carcinoma
- What is being tested?
- urine sample collection
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Feb 2024
- 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 presented with hematuria (≥ 3 RBCs/HPF) and patients with malignancy other than urothelial carcinoma in Changhai Hospital, Tongji Hospital, Renji Hospital, First Affiliated Hospital of Xian Jiaotong University, and Gulou Hospital.
Who may be able to join
- Participants aged ≥ 18 years and signed informed consent form.
- Participants presented with hematuria (≥ 3 RBCs/HPF) and meet one of the following criteria:
- Patients recommended to undergo cystoscopy or ureteroscopy;
- Patients with treatment-naïve, pathology-confirmed urothelial carcinoma;
- Patients diagnosed with benign genitourinary disease.
- Participants diagnosed with cancer other than urothelial carcinoma.
Who cannot join
- Participants with history of urothelial carcinoma.
- Participants with urothelial carcinoma accompanied by other malignancy.
- Individuals unwilling to sign the consent form or unwilling to provide urine sample for test or quality of urine sample is poor.
- Patients unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hematuria Evaluation by Whole-genome Sequencing of Urine-Exfoliated Cell DNA, A Prospective, Multi-center Study
Hematuria is recognized as an important sigh of potential urinary tract malignancy. Therefore, understanding the disease processes and discovering the potential urothelial carcinoma (UC) underlying this important sign is critical. Cystoscopy, urine cytology and imaging are most reliable methods for UC diagnosis, but certain drawbacks exist for these methods, such as invasiveness or inaccuracy. Chromosomal instability (CIN) is a hallmark of human cancer, and it's related with tumor stage and grade. Previous research has proved that analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for detecting UC. Here we intend to assess CIN's performance for hematuria evaluation.
Read the detailed description
Hematuria is defined as the presence of 3 or more red blood cells per high-power field (RBC/HPF) under microscopic examination of the urine, which is an important sigh of genitourinary system disease, especially UC. Several methods can be adopted for hematuria evaluation. Cystoscopy is a key component of the hematuria evaluation because it is a reliable way to evaluate the bladder and urethra. Biopsy can also be performed through cystoscopy, making it the "gold standard" for bladder cancer diagnosis. Despite its high reliability and accuracy, it's an invasive examination related with complications such as injury to the urethra, infection, and discomfort. Flat lesions may also be omitted under cystoscopy. Urine cytology is another important method for UC evaluation, but it has a sensitivity of only 15.8%-54.5%.
CIN refers to the ongoing acquisition of genomic alterations, it can range from point mutations to small-scale genomic alterations and gross chromosomal rearrangements. 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN is presented in UC and it has been adopted as a diagnostic method for UC, such as UroVysion test. Previously, CIN detected by low-coverage whole genome sequencing proved to be a reliable method for UC diagnosis and was named as Urine Exfoliated Cells Copy Number Aberration Detector (UroCAD). In this prospective, multi-canter, observational clinical trial, we intend to assess the possibility of UroCAD as an additional diagnostic tool for hematuria patients by collecting and analyzing 30 ml of urine sample from hematuria patient across 5 centers.
- Conditions
- Hematuria, Urothelial Carcinoma
- Being tested
- urine sample collection
- Keywords
- non-invasive, urothelial carcinoma, hematuria evaluation
- Medical subject headings
- Hematuria, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine sample collectionDiagnostic test
The level of CIN The extracted DNA from urine exfoliated cells will be analyzed by UroCAD to determine the level of CIN.
| Study group | Role | What they receive |
|---|---|---|
| Hematuria patients | Hematuria patients (≥ 3 RBCs/HPF) with treatment-naïve, pathology-confirmed urothelial carcinoma or benign genitourinary system disease or with undetermined lesion presented with hematuria. Receives: Diagnostic Test: urine sample collection | |
| Non-hematuria patients | Patients without hematuria and diagnosed with pathology-confirmed cancer other than urothelial cancer. Receives: Diagnostic Test: urine sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity
Comparison of the sensitivity of the UroCAD analysis versus clinically-acceptable threshold, defined as 75%.
Measured: through study completion, an average of 8 months
specificity
Comparison of the specificity of the UroCAD analysis versus clinically-acceptable threshold, defined as 95%.
Measured: through study completion, an average of 8 months
Sensitivity among hematuria patients
Sensitivity of UroCAD in detecting urothelial carcinoma among hematuria patients
Measured: through study completion, an average of 8 months
Specificity among hematuria patients
Specificity of UroCAD in detecting urothelial carcinoma among hematuria patients
Measured: through study completion, an average of 8 months
Secondary outcomes (2)
Comparison of Sensitivity
Comparison of the sensitivity of the UroCAD analysis versus urine cytology
Measured: through study completion, an average of 8 months
Comparison of Specificity
Comparison of the Specificity of the UroCAD analysis versus urine cytology
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HematuriaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, RenJi Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Shuxiong Zeng, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893316
- Sponsor's protocol ID
- CH-Hematuria-CIN
- Status last verified
- May 2023
- First submitted
- 29 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not public for privacy protection purpose. Data without private information may be provided on request.
Publications
Sansregret L, Vanhaesebroeck B, Swanton C. Determinants and clinical implications of chromosomal instability in cancer. Nat Rev Clin Oncol. 2018 Mar;15(3):139-150. doi: 10.1038/nrclinonc.2017.198. Epub 2018 Jan 3.
PubMed 29297505McDougal, W. Scott, et al. Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences, 2015.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematuria Evaluation by Whole-genome Sequencing of Urine-Exfoliated Cell DNA, A Prospective, Multi-center Study
- ClinicalTrials.gov ID
- NCT05893316
- Acronym / sponsor ID
- CH-Hematuria-CIN
- Conditions
- Hematuria, Urothelial Carcinoma
- Keywords
- non-invasive, urothelial carcinoma, hematuria evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Tongji Hospital, RenJi Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 7 Jun 2023 (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.
Hematuria is recognized as an important sigh of potential urinary tract malignancy. Therefore, understanding the disease processes and discovering the potential urothelial carcinoma (UC) underlying this important sign is critical. Cystoscopy, urine cytology and imaging are most reliable methods for UC diagnosis, but certain drawbacks exist for these methods, such as invasiveness or inaccuracy. Chromosomal instability (CIN) is a hallmark of human cancer, and it's related with tumor stage and grade. Previous research has proved that analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for detecting UC. Here we intend to assess CIN's performance for hematuria evaluation.
Detailed description
Hematuria is defined as the presence of 3 or more red blood cells per high-power field (RBC/HPF) under microscopic examination of the urine, which is an important sigh of genitourinary system disease, especially UC. Several methods can be adopted for hematuria evaluation. Cystoscopy is a key component of the hematuria evaluation because it is a reliable way to evaluate the bladder and urethra. Biopsy can also be performed through cystoscopy, making it the "gold standard" for bladder cancer diagnosis. Despite its high reliability and accuracy, it's an invasive examination related with complications such as injury to the urethra, infection, and discomfort. Flat lesions may also be omitted under cystoscopy. Urine cytology is another important method for UC evaluation, but it has a sensitivity of only 15.8%-54.5%.
CIN refers to the ongoing acquisition of genomic alterations, it can range from point mutations to small-scale genomic alterations and gross chromosomal rearrangements. 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN is presented in UC and it has been adopted as a diagnostic method for UC, such as UroVysion test. Previously, CIN detected by low-coverage whole genome sequencing proved to be a reliable method for UC diagnosis and was named as Urine Exfoliated Cells Copy Number Aberration Detector (UroCAD). In this prospective, multi-canter, observational clinical trial, we intend to assess the possibility of UroCAD as an additional diagnostic tool for hematuria patients by collecting and analyzing 30 ml of urine sample from hematuria patient across 5 centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematuria patients | – | Diagnostic Test: urine sample collectionHematuria patients (≥ 3 RBCs/HPF) with treatment-naïve, pathology-confirmed urothelial carcinoma or benign genitourinary system disease or with undetermined lesion presented with hematuria. |
| Non-hematuria patients | – | Diagnostic Test: urine sample collectionPatients without hematuria and diagnosed with pathology-confirmed cancer other than urothelial cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presented with hematuria (≥ 3 RBCs/HPF) and patients with malignancy other than urothelial carcinoma in Changhai Hospital, Tongji Hospital, Renji Hospital, First Affiliated Hospital of Xian Jiaotong University, and Gulou Hospital.
Key inclusion criteria (6 listed)
- Participants aged ≥ 18 years and signed informed consent form.
- Participants presented with hematuria (≥ 3 RBCs/HPF) and meet one of the following criteria:
- Participants diagnosed with cancer other than urothelial carcinoma.
Key exclusion criteria (4 listed)
- Participants with history of urothelial carcinoma.
- Participants with urothelial carcinoma accompanied by other malignancy.
- Individuals unwilling to sign the consent form or unwilling to provide urine sample for test or quality of urine sample is poor.
- Patients unsuitable for this clinical trial.
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 |
|---|---|---|
| urine sample collectionThe level of CIN The extracted DNA from urine exfoliated cells will be analyzed by UroCAD to determine the level of CIN. | Diagnostic test | Hematuria patients, Non-hematuria patients |
Primary outcome
sensitivity
Time frame: through study completion, an average of 8 months
Comparison of the sensitivity of the UroCAD analysis versus clinically-acceptable threshold, defined as 75%.
specificity
Time frame: through study completion, an average of 8 months
Comparison of the specificity of the UroCAD analysis versus clinically-acceptable threshold, defined as 95%.
Sensitivity among hematuria patients
Time frame: through study completion, an average of 8 months
Sensitivity of UroCAD in detecting urothelial carcinoma among hematuria patients
Specificity among hematuria patients
Time frame: through study completion, an average of 8 months
Specificity of UroCAD in detecting urothelial carcinoma among hematuria patients
2 secondary outcomes
Comparison of Sensitivity
Time frame: through study completion, an average of 8 months
Comparison of Specificity
Time frame: through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 29297505Sansregret L, Vanhaesebroeck B, Swanton C. Determinants and clinical implications of chromosomal instability in cancer. Nat Rev Clin Oncol. 2018 Mar;15(3):139-150. doi: 10.1038/nrclinonc.2017.198. Epub 2018 Jan 3.
- BackgroundMcDougal, W. Scott, et al. Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences, 2015.
- Individual participant dataSharing planned: No. Individual participant data are not public for privacy protection purpose. Data without private information may be provided on request.
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Hematuria - Cause Not Known
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.
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 Hematuria and Urothelial Carcinoma, 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 6 inclusion and 4 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 7 Jun 2023. 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. (+8618930568759, zengshuxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity (time frame: through study completion, an average of 8 months). The study lists 4 primary outcomes in all. 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 NCT05893316, which also lists 2 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 7 Jun 2023.