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Development of Diagnostics and Treatment of Urological Cancers (DEDUCER)

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ClinicalTrials.gov Identifier: NCT02994758
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Antti Rannikko, 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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Kidney Cancer Urothelial Carcinoma Testicular Cancer Penile Cancer Other: Personalised treatment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Diagnostics and Treatment of Urological Cancers
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Personalised medicine arm
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
Treatment based on NGS or DSRT




Primary Outcome Measures :
  1. Successful clinical translation [ Time Frame: 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 :
  1. Successful pre-clinical translation [ Time Frame: 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.

  2. Translation of preclinical data into clinically useful data. [ Time Frame: 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.

  3. Number of representative cell models developed from clinical samples. [ Time Frame: Up to 24 months ]
    Representativeness is based on the genetics of the cell model and the parental tumor



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is able to provide written informed consent and is at least 18 years of age
  2. The patient must have a verified diagnosis of an urologic cancer by a board-certified clinician

Exclusion Criteria:

  1. The patient is not willing to provide a written informed consent
  2. The patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994758


Contacts
Contact: Antti S Rannikko, MD, PhD +35894711 antti.rannikko@hus.fi

Locations
Finland
Helsinki University Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Antti s Rannikko, MD, PhD       antti.rannikko@hus.fi   
Sub-Investigator: Östling Päivi, PhD         
Sub-Investigator: Tuomas Mirtti, PhD         
Sub-Investigator: Petri Bono, PhD         
Sub-Investigator: Harry Nisen, PhD         
Sub-Investigator: Katriina Peltola, PhD         
Sub-Investigator: Olli Kallioniemi, PhD         
Sub-Investigator: Jukka Sairanen, PhD         
Sub-Investigator: Petrus Järvinen, PhD         
Sub-Investigator: Henrikki Santti, PhD         
Sub-Investigator: Anssi Petas, PhD         
Sub-Investigator: Mika Matikainen, PhD         
Sub-Investigator: Riikka Järvinen, PhD         
Sub-Investigator: Hanna Vasarainen, PhD         
Sub-Investigator: Tuomas Kilpeläinen, PhD         
Sub-Investigator: Mauri Kouri, PhD         
Sub-Investigator: Tapio Utriainen, PhD         
Sub-Investigator: Kimmo Taari, PhD         
Sub-Investigator: Vesa Rahkama, MSc         
Sub-Investigator: Andrew Erickson, MSc         
Sub-Investigator: Saeed Khalid, MSc         
Sub-Investigator: Maija Puhka, PhD         
Sub-Investigator: Vilja Pietiäinen, PhD         
Sub-Investigator: Lassi Paavolainen, MSc         
Sub-Investigator: Dmitry Bykhov, MSc         
Sub-Investigator: Teijo Pellinen, PhD         
Sub-Investigator: Sami Blom, MSc         
Sub-Investigator: Taija af Hällström, PhD         
Sub-Investigator: Kevin Sandeman, MD         
Sub-Investigator: Anu Kenttämies, PhD         
Sub-Investigator: Outi Oksanen, MD         
Sub-Investigator: Jarkko Pajarinen, PhD         
Sub-Investigator: Jari Siironen, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
Karolinska Institutet
Investigators
Principal Investigator: Antti S Rannikko, MD, PhD Helsinki University Central Hospital

Publications of Results:
Responsible Party: Antti Rannikko, Senior consultant, urology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02994758     History of Changes
Other Study ID Numbers: None yet
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antti Rannikko, Helsinki University Central Hospital:
Prostate
bladder
renal
NGS
DSRT
drug screening
sequencing
personalised medicine

Additional relevant MeSH terms:
Testicular Neoplasms
Carcinoma
Kidney Neoplasms
Carcinoma, Transitional Cell
Prostatic Neoplasms
Penile Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Penile Diseases