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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02994758
Other study ID # None yet
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2017
Est. completion date December 2025

Study information

Verified date March 2022
Source Helsinki University Central Hospital
Contact Antti S Rannikko, MD, PhD
Phone +35894711
Email antti.rannikko@hus.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Personalised treatment
Treatment based on NGS or DSRT

Locations

Country Name City State
Finland Helsinki University Hospital Helsinki Uusimaa

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Central Hospital Karolinska Institutet

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Saeed K, Ojamies P, Pellinen T, Eldfors S, Turkki R, Lundin J, Järvinen P, Nisen H, Taari K, Af Hällström TM, Rannikko A, Mirtti T, Kallioniemi O, Östling P. Clonal heterogeneity influences drug responsiveness in renal cancer assessed by ex vivo drug test — View 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, Östling P, Af Hällström TM. Comprehensive Drug Testing of Patient-derived Condit — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 24 months
Secondary 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. Up to 24 months
Secondary 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. Up to 24 months
Secondary Number of representative cell models developed from clinical samples. Representativeness is based on the genetics of the cell model and the parental tumor Up to 24 months
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