A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up

NCT04432909 | Unknown

• 1 other identifier: CH-urothelial-cancer-marker
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Urothelial carcinoma (UC) is common malignancy and is considered to be one of the costliest 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. The investigators here intended to investigate whether UroCAD can be used in UC patient follow-up and further validate the accuracy of UroCAD in diagnosing UC.

Conditions

Urothelial Carcinoma

Keywords

diagnosis; follow-up

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of urinalysis by UroCAD analysis

  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.

  through study completion, an average of 30 months

• Assess the value of UroCAD for urothelial cancer patient follow-up

  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

  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

  through study completion, an average of 30 months

• Identification of the correlation between the level of CNV and the stage of the tumor sample

  through study completion, an average of 30 months

• Comparison of the sensitivity and specificity of the UroCAD analysis versus urine cytology

  through study completion, an average of 30 months

Study Arms (2)

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

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

Interventions

The level of CNV DIAGNOSTIC_TEST

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.

Also known as: UroCAD test of the urine exfoliated cells

Non-cancer participants; Urothelial carcinoma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• RenJi Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Tongji Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Xibei Hospital: collaborator
• West China Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (4)

• Wadhwa N, Mathew BB, Jatawa SK, Tiwari A. Genetic instability in urinary bladder cancer: An evolving hallmark. J Postgrad Med. 2013 Oct-Dec;59(4):284-8. doi: 10.4103/0022-3859.123156.

  PMID: 24346386 BACKGROUND

• Bakhoum SF, Ngo B, Laughney AM, Cavallo JA, Murphy CJ, Ly P, Shah P, Sriram RK, Watkins TBK, Taunk NK, Duran M, Pauli C, Shaw C, Chadalavada K, Rajasekhar VK, Genovese G, Venkatesan S, Birkbak NJ, McGranahan N, Lundquist M, LaPlant Q, Healey JH, Elemento O, Chung CH, Lee NY, Imielenski M, Nanjangud G, Pe'er D, Cleveland DW, Powell SN, Lammerding J, Swanton C, Cantley LC. Chromosomal instability drives metastasis through a cytosolic DNA response. Nature. 2018 Jan 25;553(7689):467-472. doi: 10.1038/nature25432. Epub 2018 Jan 17.

  PMID: 29342134 BACKGROUND

• Liu H, He W, Wang B, Xu K, Han J, Zheng J, Ren J, Shao L, Bo S, Lu S, Lin T, Huang J. MALBAC-based chromosomal imbalance analysis: a novel technique enabling effective non-invasive diagnosis and monitoring of bladder cancer. BMC Cancer. 2018 Jun 15;18(1):659. doi: 10.1186/s12885-018-4571-7.

  PMID: 29907142 BACKGROUND

• Hieronymus H, Murali R, Tin A, Yadav K, Abida W, Moller H, Berney D, Scher H, Carver B, Scardino P, Schultz N, Taylor B, Vickers A, Cuzick J, Sawyers CL. Tumor copy number alteration burden is a pan-cancer prognostic factor associated with recurrence and death. Elife. 2018 Sep 4;7:e37294. doi: 10.7554/eLife.37294.

  PMID: 30178746 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA from Urine Exfoliated Cells will be analyzed

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chuanliang Xu, M.D.,Ph.D.

  Changhai Hospital, Shanghai

  STUDY CHAIR

Central Study Contacts

Shuxiong Zeng, M.D., Ph.D.

CONTACT

+8618930568759; zengshuxiong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: January 17, 2020
• Primary Completion: January 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)