Development of Diagnostics and Treatment of Urological Cancers

NCT02994758 | Unknown

• 1 other identifier: None yet
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma; Kidney Cancer; Urothelial Carcinoma; Testicular Cancer; Penile Cancer

Keywords

Prostate; bladder; renal; NGS; DSRT; drug screening; sequencing; personalised medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Successful pre-clinical translation

  Up to 24 months

• Translation of preclinical data into clinically useful data.

  Up to 24 months

• Number of representative cell models developed from clinical samples.

  Up to 24 months

Study Arms (1)

Personalised medicine arm

OTHER

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

Interventions

Personalised treatment OTHER

Treatment based on NGS or DSRT

Personalised medicine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is able to provide written informed consent and is at least 18 years of age
• The patient must have a verified diagnosis of an urologic cancer by a board-certified clinician

You may not qualify if:

• The patient is not willing to provide a written informed consent
• The patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

Related Publications (2)

• 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.

  PMID: 27160946 RESULT

• 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.

  PMID: 30125350 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms; Carcinoma, Transitional Cell; Testicular Neoplasms; Penile Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Antti S Rannikko, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antti S Rannikko, MD, PhD

CONTACT

+35894711; antti.rannikko@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, urology

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 16, 2016
• Study Start: November 27, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

FI (1)