Development of Diagnostics and Treatment of Urological Cancers

NCT ID: NCT02994758

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-27

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Prostate Carcinoma Kidney Cancer Urothelial Carcinoma Testicular Cancer Penile Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Personalised treatment

Intervention Type OTHER

Treatment based on NGS or DSRT

Interventions

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Personalised treatment

Treatment based on NGS or DSRT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antti Rannikko

Senior consultant, urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antti S Rannikko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, Uusimaa, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Antti S Rannikko, MD, PhD

Role: CONTACT

+35894711

Facility Contacts

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Antti s Rannikko, MD, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 27160946 (View on PubMed)

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.

Reference Type RESULT
PMID: 30125350 (View on PubMed)

Other Identifiers

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None yet

Identifier Type: -

Identifier Source: org_study_id

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