Development of Diagnostics and Treatment of Urological Cancers

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether state-of-the-art technologies such and next generation sequencing and drug sensitivity and resistance testing of patient derived tumour tissue can facilitate research translation and improve outcome of urologic cancers.

Detailed Description
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Access to high-quality clinical patient material (e.g. tissue of primary tumor and metastasis, plasma and urine) linked to comprehensive registry and clinical data and molecular characterization of the patient material using state-of-the-art technologies (e.g. NGS, transcriptomics, imaging, DSRT) will facilitate a more rapid translation of basic research innovations into clinical care (diagnostics, imaging, therapeutics) and result in improved outcome of patients suffering from urologic cancers (personalized medicine). The principal aim of the project is to establish a framework and infrastructure for the systematic collection and interpretation of biological patient samples. Similarly, the investigators aim to establish the format how the related clinical and research data can be made readily accessible for both clinicians and researchers without compromising patient privacy. The key objectives of the project are to facilitate research translation and to improve outcome of urologic cancers.

Official Title
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Development of Diagnostics and Treatment of Urological Cancers

Conditions
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Prostate Carcinoma, Kidney Cancer, Urothelial Carcinoma, Testicular Cancer, Penile Cancer

Intervention / Treatment
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* Other: Personalised treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is able to provide written informed consent and is at least 18 years of age The patient must have a verified diagnosis of an urologic cancer by a board-certified clinician Exclusion Criteria: The patient is not willing to provide a written informed consent The patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Personalised medicine arm<br>This is a prospective n-of-1 type of trial where every patient is his/her own control. This is a study further developing the translational use of an existing framework and infrastructure for systematic sample collection an analytics previously established in the HUB project incorporating NGS and DSRT into clinical care. | Other: Personalised treatment<br>* Treatment based on NGS or DSRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful clinical translation | The magnitude of successful clinical translation is measured by the number of times project-derived personalized medicine has impacted patients care by application of novel and existing biomarkers and therapies (e.g. sequencing, DSRT) by 2020 | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful pre-clinical translation | Successful pre-clinical translation, the magnitude of which is measured by the number of times project-derived potential druggable targets or able to re-purpose treatment options were identified within the project by 2020. | Up to 24 months | 
| Translation of preclinical data into clinically useful data. | Translation of preclinical data into clinically useful data. The success of which is measured by the number of times preclinical data (e.g. sequencing, DSRT) was transformed into clinically useful form within 4 weeks from the time the initial sampling of the specimen was done. | Up to 24 months | 
| Number of representative cell models developed from clinical samples. | Representativeness is based on the genetics of the cell model and the parental tumor | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, bladder, renal, NGS, DSRT, drug screening, sequencing, personalised medicine