Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Prostatic Neoplasms

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Testicular Neoplasms

Kidney Neoplasms

Penile Neoplasms

Urologic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Penile Diseases

Renal Cell Carcinoma

Transitional Cell Carcinoma

Penile Cancer

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.

Personalised treatment

Antti S Rannikko, MD, PhD

Antti s Rannikko, MD, PhD

Östling Päivi, PhD

Tuomas Mirtti, PhD

Petri Bono, PhD

Harry Nisen, PhD

Katriina Peltola, PhD

Olli Kallioniemi, PhD

Jukka Sairanen, PhD

Petrus Järvinen, PhD

Henrikki Santti, PhD

Anssi Petas, PhD

Mika Matikainen, PhD

Riikka Järvinen, PhD

Hanna Vasarainen, PhD

Tuomas Kilpeläinen, PhD

Mauri Kouri, PhD

Tapio Utriainen, PhD

Kimmo Taari, PhD

Vesa Rahkama, MSc

Andrew Erickson, MSc

Saeed Khalid, MSc

Maija Puhka, PhD

Vilja Pietiäinen, PhD

Lassi Paavolainen, MSc

Dmitry Bykhov, MSc

Teijo Pellinen, PhD

Sami Blom, MSc

Taija af Hällström, PhD

Kevin Sandeman, MD

Anu Kenttämies, PhD

Outi Oksanen, MD

Jarkko Pajarinen, PhD

Jari Siironen, PhD

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.

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.

Development of Diagnostics and Treatment of Urological Cancers

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

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. 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.

Representativeness is based on the genetics of the cell model and the parental tumor

Karolinska Institutet

Helsinki University Central Hospital

Senior consultant, urology

Adenocarcinoma

All Drugs and Chemicals

Gastrointestinal Agents

Immunomodulating Agents

Pancrelipase

Pancreatin

Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing.

Investigators are allowed to chose the best option of standard treatment for patients.

Personalised treatments include chemotherapy, targeted therapy, immunotherapy or others based on the previous test results, chosen from a database that include more than 2000 different drugs.

Investigators are allowed to chose what they consider the best standard treatment option for their patients.

Treatment chosen per investigator´s judge

Manuel Hidalgo, PhD

This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line.

This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas.

Patients with metastatic disease will be randomised to the experimental or control arms. Those in the experimental arm will undergone a tumoral biopsy in order to perform exome sequencing, bioinformatic report, and avatar mouse models for drug testing. This information will allow the expertise panel to elaborate a treatment recommendation as second or third lines of treatment. Patients in the control arm will receive treatment as per investigator´s judge. The main objective of the trial is to determine whether personalised treatments achieve improved 1-year overall survival.

Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation

Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation

Hospital Universitario de Fuenlabrada

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of Diagnostics and Treatment of Urological Cancers	NCT02994758	Prostate Carcin... Kidney Cancer Urothelial Carc... Testicular Canc... Penile Cancer	Personalised tr...	18 Years -	Helsinki University Central Hospital
Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation	NCT02795650	Adenocarcinoma	Personalised tr... Treatment chose...	18 Years -	Hospital Universitario de Fuenlabrada
Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation	NCT02795650	Adenocarcinoma	Personalised tr... Treatment chose...	18 Years -	Hospital Universitario de Fuenlabrada
Development of Diagnostics and Treatment of Urological Cancers	NCT02994758	Prostate Carcin... Kidney Cancer Urothelial Carc... Testicular Canc... Penile Cancer	Personalised tr...	18 Years -	Helsinki University Central Hospital

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