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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
Sponsor:
Collaborators:
RenJi Hospital
The First Affiliated Hospital of Soochow University
Zhejiang Provincial People's Hospital
Tongji Hospital
Tianjin Medical University Second Hospital
Qilu Hospital of Shandong University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Xibei Hospital
West China Hospital
Information provided by (Responsible Party):
Shuxiong Zeng, Changhai Hospital

Brief Summary:
Urothelial carcinoma (UC) is common malignancy and is considered to be one of the most expensive cancers. The traditional diagnostic methods of UC present with some shortcomings. For example, the specificity of CTU remains low while cystoscopy is invasive and expensive. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. 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 UC with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in UC patient follow-up hasn't been assessed yet and the the accuracy of UroCAD in detecting UC still need to be further validated. We here intended to investigate whether UroCAD can be used in UC patient follow-up and further validate the accuracy of UroCAD in diagnosing UC.

Condition or disease Intervention/treatment
Urothelial Carcinoma Diagnostic Test: The level of CNV

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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
DNA from Urine Exfoliated Cells will be analyzed


Information from the National Library of Medicine

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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
Study Population
Patients diagnosed with urothelial carcinoma or participants in control group from January 2020 to June 2022 in 10 hospitals including Changhai hospital, Renji hospital, The First Affiliated Hospital of Suchow university, Zhejiang Provincial people's hospital, Tongji hospital, The second hospital of Tianjin medical university, Qilu hospital, Second Affiliated Hospital of Sun Yat-Sen University, Xibei hospital, West China hospital.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shuxiong Zeng, M.D., Ph.D. +8618930568759 zengshuxiong@126.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Shuxiong Zeng, M.D. Ph.D    +8618930568759    zengshuxiong@126.com   
Sponsors and Collaborators
Changhai Hospital
RenJi Hospital
The First Affiliated Hospital of Soochow University
Zhejiang Provincial People's Hospital
Tongji Hospital
Tianjin Medical University Second Hospital
Qilu Hospital of Shandong University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Xibei Hospital
West China Hospital
Investigators
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Study Chair: Chuanliang Xu, M.D.,Ph.D. Changhai Hospital, Shanghai
Publications:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shuxiong Zeng, Changhai Hospital:
diagnosis
follow-up
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms