Clinical trial NCT02994758: Development of Diagnostics and Treatment of Urological Cancers
Official title: Development of Diagnostics and Treatment of Urological Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Kidney Cancer
Urothelial Carcinoma
Testicular Cancer
Penile Cancer
Keywords: Prostate
bladder
renal
NGS
DSRT
drug screening
sequencing
personalised medicine
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Successful clinical translation
timeFrame: Up to 24 months
Secondary outcomes:
measure: Successful pre-clinical translation
timeFrame: Up to 24 months
measure: Translation of preclinical data into clinically useful data.
timeFrame: Up to 24 months
measure: Number of representative cell models developed from clinical samples.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Antti S Rannikko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.