Bladder Cancer Clinical Trial
Official title:
Evaluation of Genomic Imprinting Testing for Detection and Surveillance of Bladder Cancer Patients
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.
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.
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