Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-11 @ 8:36 PM
Study NCT ID:
NCT02994758
Status:
RECRUITING
Last Update Posted:
2022-03-11
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Diagnostics and Treatment of Urological Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}, {'id': 'D010412', 'term': 'Penile Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010409', 'term': 'Penile Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful clinical translation', 'timeFrame': 'Up to 24 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Successful pre-clinical translation', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Translation of preclinical data into clinically useful data.', 'timeFrame': 'Up to 24 months', 'description': '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.'}, {'measure': 'Number of representative cell models developed from clinical samples.', 'timeFrame': 'Up to 24 months', 'description': 'Representativeness is based on the genetics of the cell model and the parental tumor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate', 'bladder', 'renal', 'NGS', 'DSRT', 'drug screening', 'sequencing', 'personalised medicine'], 'conditions': ['Prostate Carcinoma', 'Kidney Cancer', 'Urothelial Carcinoma', 'Testicular Cancer', 'Penile Cancer']}, 'referencesModule': {'references': [{'pmid': '27160946', 'type': 'RESULT', '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.'}, {'pmid': '30125350', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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").\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is able to provide written informed consent and is at least 18 years of age\n2. The patient must have a verified diagnosis of an urologic cancer by a board-certified clinician\n\nExclusion Criteria:\n\n1. The patient is not willing to provide a written informed consent\n2. The patient has a severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02994758', 'acronym': 'DEDUCER', 'briefTitle': 'Development of Diagnostics and Treatment of Urological Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Development of Diagnostics and Treatment of Urological Cancers', 'orgStudyIdInfo': {'id': 'None yet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Personalised medicine arm', 'description': '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.', 'interventionNames': ['Other: Personalised treatment']}], 'interventions': [{'name': 'Personalised treatment', 'type': 'OTHER', 'description': 'Treatment based on NGS or DSRT', 'armGroupLabels': ['Personalised medicine arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Antti s Rannikko, MD, PhD', 'role': 'CONTACT', 'email': 'antti.rannikko@hus.fi'}, {'name': 'Östling Päivi, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tuomas Mirtti, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Petri Bono, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Harry Nisen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katriina Peltola, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olli Kallioniemi, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jukka Sairanen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Petrus Järvinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Henrikki Santti, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anssi Petas, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mika Matikainen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Riikka Järvinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanna Vasarainen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tuomas Kilpeläinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mauri Kouri, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tapio Utriainen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kimmo Taari, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vesa Rahkama, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrew Erickson, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Saeed Khalid, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maija Puhka, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vilja Pietiäinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lassi Paavolainen, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dmitry Bykhov, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teijo Pellinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sami Blom, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taija af Hällström, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kevin Sandeman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anu Kenttämies, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Outi Oksanen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jarkko Pajarinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jari Siironen, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Antti S Rannikko, MD, PhD', 'role': 'CONTACT', 'email': 'antti.rannikko@hus.fi', 'phone': '+35894711'}], 'overallOfficials': [{'name': 'Antti S Rannikko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, urology', 'investigatorFullName': 'Antti Rannikko', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}