DEDUCER: Development of Diagnostics and Treatment of Urological Cancers

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02994758
Collaborator
Karolinska Institutet (Other)
100
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1
96.1
1

Study Details

Study Description

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
  • Other: Personalised treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
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 :
Nov 27, 2017
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Helsinki Uusimaa Finland 00029

Sponsors and Collaborators

  • Helsinki University Central Hospital
  • Karolinska Institutet

Investigators

  • Principal Investigator: Antti S Rannikko, MD, PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antti Rannikko, Senior consultant, urology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT02994758
Other Study ID Numbers:
  • None yet
First Posted:
Dec 16, 2016
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Senior consultant, urology, Helsinki University Central Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022