Development of Diagnostics and Treatment of Urological Cancers (DEDUCER)

March 10, 2022 updated by: Antti Rannikko, Helsinki University Central Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital
        • 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:
          • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months
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.
Up to 24 months
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 27, 2017

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • None yet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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