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Application of UCAD for Diagnosing Urothelial Carcinoma.

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ClinicalTrials.gov Identifier: NCT03998371
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Shuxiong Zeng, Changhai Hospital

Brief Summary:
Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of bladder cancer patients. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. We here intend to study whether a new method named Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN thus help diagnosing and treating bladder cancer patients.

Condition or disease Intervention/treatment
Urothelial Carcinoma Diagnoses Disease Chromosomal Abnormality Urine Marking Diagnostic Test: Low-coverage whole-genome sequencing of urine exfoliated cells

Detailed Description:

CIN results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially non-invasive way to detect CIN in the urothelial cells from the urine sample for diagnosing and monitoring bladder cancer patients. UCAD is a new method to detecting CIN in the DNA sample from patients, including extracting DNA from urine, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of bladder cancer patients.

The investigators intended to conduct a prospective study by analyzing urine samples from bladder cancer patients and control groups that without any tumor in the urinary system or other organs to compare the specificity and sensitivity of UCAD test for diagnosing urothelial carcinoma to other modalities, such as urine cytology or fluorescence in situ hybridization (FISH).

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) in Urine Exfoliated Cells for Diagnosis of Urothelial Carcinoma in in Urine Exfoliated Cells
Actual Study Start Date : May 5, 2019
Estimated Primary Completion Date : May 5, 2020
Estimated Study Completion Date : May 5, 2020

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 UCAD analysis, the result will be compared with cytology and FISH.
Diagnostic Test: Low-coverage whole-genome sequencing of urine exfoliated cells
The level of CIN The extracted DNA from morning urine will be analyzed by UCAD to determine the level of CIN.

Non-cancer participants group
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 UCAD analysis.
Diagnostic Test: Low-coverage whole-genome sequencing of urine exfoliated cells
The level of CIN The extracted DNA from morning urine will be analyzed by UCAD to determine the level of CIN.




Primary Outcome Measures :
  1. Sensitivity of urinalysis by UCAD analysis [ Time Frame: Up to 1 years ]
    Number of patients "declared positive" with the UCAD test among the patients suffered from urothelial carcinoma.

  2. Specificity of urinalysis by UCAD analysis [ Time Frame: Through study completion, an average of 12 months ]
    Number of patients "declared negative" with the UCAD test among the patients without cancer.


Secondary Outcome Measures :
  1. Comparison of the sensitivity of the UCAD analysis versus urine cytology [ Time Frame: Up to 1 years ]
    Number of patients "declared positive" with the UCAD analysis versus patients "declared positive" with the urine cytology.

  2. Comparison of the specificity of the UCAD analysis versus urine cytology [ Time Frame: Up to 1 years ]
    Number of patients "declared negative" with the UCAD analysis versus patients " declared negative " with the urine cytology.


Other Outcome Measures:
  1. Identification of the correlation between the level of CIN and the grade of the tumor sample [ Time Frame: Up to 1 years ]
    Level of CIN in the urine sample compared with the grade of the tumor confirmed by histopathologic examination

  2. Identification of the correlation between the level of CIN and the stage of the tumor sample [ Time Frame: Up to 1 years ]
    Level of CIN in the urine sample compared with the stage of the tumor confirmed by histopathologic examination.


Biospecimen Retention:   Samples With DNA
DNA from Urine Exfoliated Cells will be analyzed by Ultrasensitive Chromosomal Aneuploidy Detection


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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 in Changhai Hospital from May 2019 till the end of this study.
Criteria

Inclusion Criteria:

  • Patients diagnosed with urothelial carcinoma and planned to undergo surgery.
  • 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.
  • Individuals unwilling to participate in this trial.

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): NCT03998371


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
Investigators
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Study Chair: Chuangliang Xu, M.D., Ph.D Changhai Hospital
Publications:
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Responsible Party: Shuxiong Zeng, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03998371    
Other Study ID Numbers: CH-urology-bladder marker-002
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 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:
Urothelial Carcinoma
diagnosis
Chromosomal Aneuploidy Detection
marker
urine
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Chromosome Disorders
Chromosome Aberrations
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Congenital Abnormalities
Pathologic Processes
Genetic Diseases, Inborn