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

Tracking Information

• First Submitted Date: December 1, 2016
• First Posted Date: December 16, 2016
• Last Update Posted Date: March 11, 2022
• Actual Study Start Date: November 27, 2017
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 13, 2016)

• 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.
• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of Diagnostics and Treatment of Urological Cancers
• Official Title: Development of Diagnostics and Treatment of Urological Cancers
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Prostate Carcinoma
• Kidney Cancer
• Urothelial Carcinoma
• Testicular Cancer
• Penile Cancer

Intervention

Other: Personalised treatment

Treatment based on NGS or DSRT

Study Arms

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.

Intervention: Other: Personalised treatment

Publications *

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 13, 2016): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT02994758
• Other Study ID Numbers: None yet
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Antti Rannikko, Helsinki University Central Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Helsinki University Central Hospital
• Original Study Sponsor: Same as current
• Collaborators: Karolinska Institutet

Investigators

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

• PRS Account: Helsinki University Central Hospital
• Verification Date: March 2022