Development of Diagnostics and Treatment of Urological Cancers (DEDUCER)
Primary Purpose
Prostate Carcinoma, Kidney Cancer, Urothelial Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Personalised treatment
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Carcinoma focused on measuring Prostate, bladder, renal, NGS, DSRT, drug screening, sequencing, personalised medicine
Eligibility Criteria
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
Sites / Locations
- Helsinki University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Personalised medicine arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Number of representative cell models developed from clinical samples.
Representativeness is based on the genetics of the cell model and the parental tumor
Full Information
NCT ID
NCT02994758
First Posted
December 1, 2016
Last Updated
March 10, 2022
Sponsor
Helsinki University Central Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02994758
Brief Title
Development of Diagnostics and Treatment of Urological Cancers
Acronym
DEDUCER
Official Title
Development of Diagnostics and Treatment of Urological Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma, Kidney Cancer, Urothelial Carcinoma, Testicular Cancer, Penile Cancer
Keywords
Prostate, bladder, renal, NGS, DSRT, drug screening, sequencing, personalised medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalised medicine arm
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Personalised treatment
Intervention Description
Treatment based on NGS or DSRT
Primary Outcome Measure Information:
Title
Successful clinical translation
Description
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
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Successful pre-clinical translation
Description
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.
Time Frame
Up to 24 months
Title
Translation of preclinical data into clinically useful data.
Description
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.
Time Frame
Up to 24 months
Title
Number of representative cell models developed from clinical samples.
Description
Representativeness is based on the genetics of the cell model and the parental tumor
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antti S Rannikko, MD, PhD
Phone
+35894711
Email
antti.rannikko@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti S Rannikko, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti s Rannikko, MD, PhD
Email
antti.rannikko@hus.fi
First Name & Middle Initial & Last Name & Degree
Östling Päivi, PhD
First Name & Middle Initial & Last Name & Degree
Tuomas Mirtti, PhD
First Name & Middle Initial & Last Name & Degree
Petri Bono, PhD
First Name & Middle Initial & Last Name & Degree
Harry Nisen, PhD
First Name & Middle Initial & Last Name & Degree
Katriina Peltola, PhD
First Name & Middle Initial & Last Name & Degree
Olli Kallioniemi, PhD
First Name & Middle Initial & Last Name & Degree
Jukka Sairanen, PhD
First Name & Middle Initial & Last Name & Degree
Petrus Järvinen, PhD
First Name & Middle Initial & Last Name & Degree
Henrikki Santti, PhD
First Name & Middle Initial & Last Name & Degree
Anssi Petas, PhD
First Name & Middle Initial & Last Name & Degree
Mika Matikainen, PhD
First Name & Middle Initial & Last Name & Degree
Riikka Järvinen, PhD
First Name & Middle Initial & Last Name & Degree
Hanna Vasarainen, PhD
First Name & Middle Initial & Last Name & Degree
Tuomas Kilpeläinen, PhD
First Name & Middle Initial & Last Name & Degree
Mauri Kouri, PhD
First Name & Middle Initial & Last Name & Degree
Tapio Utriainen, PhD
First Name & Middle Initial & Last Name & Degree
Kimmo Taari, PhD
First Name & Middle Initial & Last Name & Degree
Vesa Rahkama, MSc
First Name & Middle Initial & Last Name & Degree
Andrew Erickson, MSc
First Name & Middle Initial & Last Name & Degree
Saeed Khalid, MSc
First Name & Middle Initial & Last Name & Degree
Maija Puhka, PhD
First Name & Middle Initial & Last Name & Degree
Vilja Pietiäinen, PhD
First Name & Middle Initial & Last Name & Degree
Lassi Paavolainen, MSc
First Name & Middle Initial & Last Name & Degree
Dmitry Bykhov, MSc
First Name & Middle Initial & Last Name & Degree
Teijo Pellinen, PhD
First Name & Middle Initial & Last Name & Degree
Sami Blom, MSc
First Name & Middle Initial & Last Name & Degree
Taija af Hällström, PhD
First Name & Middle Initial & Last Name & Degree
Kevin Sandeman, MD
First Name & Middle Initial & Last Name & Degree
Anu Kenttämies, PhD
First Name & Middle Initial & Last Name & Degree
Outi Oksanen, MD
First Name & Middle Initial & Last Name & Degree
Jarkko Pajarinen, PhD
First Name & Middle Initial & Last Name & Degree
Jari Siironen, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27160946
Citation
Saeed K, Rahkama V, Eldfors S, Bychkov D, Mpindi JP, Yadav B, Paavolainen L, Aittokallio T, Heckman C, Wennerberg K, Peehl DM, Horvath P, Mirtti T, Rannikko A, Kallioniemi O, Ostling P, Af Hallstrom TM. Comprehensive Drug Testing of Patient-derived Conditionally Reprogrammed Cells from Castration-resistant Prostate Cancer. Eur Urol. 2017 Mar;71(3):319-327. doi: 10.1016/j.eururo.2016.04.019. Epub 2016 May 6.
Results Reference
result
PubMed Identifier
30125350
Citation
Saeed K, Ojamies P, Pellinen T, Eldfors S, Turkki R, Lundin J, Jarvinen P, Nisen H, Taari K, Af Hallstrom TM, Rannikko A, Mirtti T, Kallioniemi O, Ostling P. Clonal heterogeneity influences drug responsiveness in renal cancer assessed by ex vivo drug testing of multiple patient-derived cancer cells. Int J Cancer. 2019 Mar 15;144(6):1356-1366. doi: 10.1002/ijc.31815. Epub 2018 Nov 4.
Results Reference
result
Learn more about this trial
Development of Diagnostics and Treatment of Urological Cancers
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