Development of Diagnostics and Treatment of Urological Cancers
- Conditions
- Urothelial CarcinomaKidney CancerTesticular CancerPenile CancerProstate Carcinoma
- Interventions
- Other: Personalised treatment
- Registration Number
- NCT02994758
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Personalised medicine arm Personalised treatment 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.
- Primary Outcome Measures
Name Time Method Successful clinical translation Up to 24 months 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
- Secondary Outcome Measures
Name Time Method Successful pre-clinical translation Up to 24 months 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.
Translation of preclinical data into clinically useful data. Up to 24 months 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.
Number of representative cell models developed from clinical samples. Up to 24 months Representativeness is based on the genetics of the cell model and the parental tumor
Trial Locations
- Locations (1)
Helsinki University Hospital
🇫🇮Helsinki, Uusimaa, Finland