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PAGER

Analyses of Personal Genomic Changes in Patients with Bladder Cancer

 

Aim: The aim of this study is to use "Next Generation Sequencing" (NGS) to identify mutations and genomic changes in the DNA from patients with bladder cancer tumors. These changes will be used as patient-specific biomarkers for following the development of the illness over time. The speficic aims for the study are:

1. Identification of markers for testing of blood- and urine samples in patients with early stages of bladder cancer

2. Identification of markers for testing of blood- and urine samples in patients with bladder cancer who have been treated with chemotherapy before cycstectomy.

3. Identification of markers for testing of blood- and urine samples in patients with metastatic bladder cancer who have been treated with chemotherapy or other medicinal cancer treatment.

We will find out if it is possible to identify relapses and aggravation of the illness at an earlier time by the use of blood- and urine samples, and thus increase the chance of survival for patients with bladder cancer. 

Furthermore, we will use these personal biomarkers to investigate if it is possible to avoid repeated cystoscopies in order to spare the patients of possible pain and side effects. Additionally, this could also lessen the financial burden which is connected to the present control visits.

Additionally, we want this project to find out if we can identify the spreading of cancer at an earlier time. This would allow for medicinal treatment at an earlier time, and thus perhaps increase the patients' chance of survival.

Finally, a measurement of the treatment efficacy will ensure that the patients are offered the most relevant treatment for their cancer.

 

Participants: We wish to include up to 150 patients in part 1, and 500 patients in total for part 2 and 3.

Inclusion criteria: 

  • Patients diagnosed with non-muscle invasive bladder cancer

Exclusion criteria: 

  • Patients who at some point has been diagnosed with muscle invasive bladder cancer
  • Patients who previously has been treated with chemotherapy or other medicinal treatment for advancet metastatic bladder cancer

 

Methods: We will use genome sequecing for detection of genomic changes and mutations in the patients' tumors. These changes will be measures in DNA from blood- and urine samples from the patients, which will be analyzed with PCR or NGS methods. The project contains data from a research biobank.

 

Status: Including

 

Center:

Aarhus University Hospital.

All patients who have appointments at the department of urology or the cancer department are offered information and possible inclusion in the project via a written consent form.

 

Contact


Tine Christiansen

tinechti@rm.dk 

Phone: +45 30 91 54 59

Clinical Trial Coordinator