Development of Diagnostics and Treatment of Urological Cancers (DEDUCER)

• ClinicalTrials.gov Identifier: NCT02994758
• Recruitment Status: Recruiting
• First Posted: December 16, 2016
• Last Update Posted: March 11, 2022
• Sponsor: Helsinki University Central Hospital
• Collaborator: Karolinska Institutet
• Information provided by (Responsible Party): Antti Rannikko, Helsinki University Central Hospital

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
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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: November 27, 2017
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications of Results:

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.

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.

• Responsible Party: Antti Rannikko, Senior consultant, urology, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02994758
• Other Study ID Numbers: None yet
• First Posted: December 16, 2016
• Last Update Posted: March 11, 2022
• Last Verified: March 2022

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:

Carcinoma; Kidney Neoplasms; Testicular Neoplasms; Penile Neoplasms; Urologic Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Penile Diseases