Genomic Imprinting Testing for Diagnosis of Bladder Cancer
- Conditions
- Bladder CancerUrine MarkingDiagnoses Disease
- Interventions
- Diagnostic Test: Genomic Imprinting Testing
- Registration Number
- NCT03563443
- Lead Sponsor
- Changhai Hospital
- Brief Summary
Urine analysis provide a promising non-invasive liquid biopsy for diagnosis of bladder cancer. Molecular biomarkers in urine may serve as important diagnostic and prognostic indicators for bladder cancer. Many alterations of genes and proteins have been identified in the urinary for diagnosis of bladder cancer. However, not all bladder cancer patients have the same alterations due to tumor heterogeneity. Thus, to reach satisfactory sensitivity and specificity a new diagnostic molecular alteration should exists ubiquitously in cancers. Numerous studies indicate that Loss of imprinting (LOI) exists ubiquitously in cancers and precede morphological changes. The investigators will conduct a prospective evaluation of a panel of LOI changes in urine test for detection and surveillance of bladder cancer patients.
- Detailed Description
During the progression of tumor, molecular changes in both genomics and epigenomics occur prior to morphological changes in cells and tissues, therefore molecular biological test is more sensitive to detect cancer at early stage. Genomic imprinting is one kind of epigenetic regulation that controls gene expression. In detail, a copy of gene on the certain maternal or paternal allele is silenced through methylation, while the other acts normally. This kind of genes are named imprinting genes. Loss of imprinting and Copy number variation (LOI \& CNV) is epigenetic change that the silenced copy of an imprinting gene is activated through demethylation. Numerous studies indicate that LOI exists ubiquitously in cancers and precede morphological changes. In contrast, LOI rarely happens in normal somatic cells. Therefore, the methylation status of imprinting genes can act as a biomarker to detect and analyze the abnormal cells.
The investigators will develop a couple of common LOI to establish a predictive diagnostic LOI panel in urine with optimal and robust efficacy in diagnosis of bladder cancer by analyzing LOI in urine from bladder cancer patients and control group that without any tumor in urinary system or other organs. Moreover, the changes of LOI in urine collected before and 1 year after transurethral resection of non-muscle invasive bladder cancer (NIMBC) will also be monitored. External consistency validation will be performed on subsequent urine from patients and control participants collection.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
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- Patients diagnosed with of bladder cancer by cystoscopy and biopsy. 2. Participants without any tumor disease and willing to attend the study by providing morning urine.
- Moring urine and available tumor tissue obtained by biopsy. 4. Male or female patients aged >= 18 years. 5. Participants signed informed consent form.
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- Age under 18 years 2. Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery 3. Comorbidities that will prohibit or make serial urine collection and cystoscopic examination difficult or impossible during follow up.
- Prior diagnosis of cancer except bladder cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bladder cancer patients Genomic Imprinting Testing Diagnosed bladder cancer patients who are being monitored will be the experimental group to develop the LOI panel, and subsequent cohort will be used to confirm the sensitivity and specificity of this urinary analysis. Non-cancer participants Genomic Imprinting Testing Patients being treated for other diseases but without any tumor or healthy participants will provide a negative control to provide data for developing the LOI diagnostic panel
- Primary Outcome Measures
Name Time Method Sensitivity of urinalysis by LOI urine analysis In the middle of the study, an average of 12 months Number of patients "declared positive" with the LOI urine test among the patients suffered from bladder cancer
Specificity of urinalysis by LOI urine analysis In the middle of the study, an average of 12 months Number of patients "declared negative" with the LOI urine test among the patients who are without cancer
- Secondary Outcome Measures
Name Time Method Identification of sensitivity of urinalysis by LOI urine analysis to predict the recurrence of bladder cancer within 1 year after transurethral resection of NMIBC Through study completion, an average of 24 months Number of patients "declared positive" with the LOI urine test after bladder cancer surgery among the patients being confirmed to have bladder cancer by cystoscopic examination and biopsy
Identification of specificity of urinalysis by LOI urine analysis to predict the free of bladder cancer recurrence within 1 year after transurethral resection of NMIBC Through study completion, an average of 24 months Number of patients "declared negative" with the LOI urine test after bladder cancer surgery among the patients being confirmed to have no bladder cancer recurrence by cystoscopic examination
Comparison of the sensitivity of the urine LOI analysis versus urine cytology In the middle of the study, an average of 12 months Number of patients "declared positive" with the LOI analysis versus patients "declared positive" with the urine cytology
Comparison of the specificity of the urine LOI analysis versus urine cytology In the middle of the study, an average of 12 months Number of patients "declared negative" with the LOI analysis versus patients " declared negative " with the urine cytology
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, Shanghai, China