Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-13 @ 5:25 PM
Study NCT ID:
NCT05326620
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2022-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '5 years', 'description': 'overall survival'}, {'measure': 'progression', 'timeFrame': '5 years', 'description': 'local or distant recurrence'}, {'measure': 'patient reported outcome measures (PROMS)', 'timeFrame': '5 years', 'description': 'measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.'}], 'secondaryOutcomes': [{'measure': 'Patient reported outcomes of adverse events', 'timeFrame': '2 years', 'description': 'Measured with the PRO-CTCAE (patient-reported outcomes version of the common terminology criteria for adverse events), weekly during systemic therapy. Symptoms are scored through 0 (absent) to 3 (severe)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cancer', 'Renal Cell Carcinoma', 'Renal Cell Cancer Metastatic']}, 'referencesModule': {'references': [{'pmid': '37434119', 'type': 'DERIVED', 'citation': "Yildirim H, Widdershoven CV, Aarts MJ, Bex A, Bloemendal HJ, Bochove-Overgaauw DM, Hamberg P, Herbschleb KH, van der Hulle T, Lagerveld BW, van Oijen MG, Oosting SF, van Thienen JV, van der Veldt AA, Westgeest HM, Zeijdner EE, Aben KK, van den Hurk C, Zondervan PJ, Bins AD. The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for 'Trial within Cohorts' study designs. BMC Cancer. 2023 Jul 11;23(1):648. doi: 10.1186/s12885-023-11094-9."}], 'seeAlsoLinks': [{'url': 'http://www.pro-rcc.nl', 'label': 'official study and foundation website'}]}, 'descriptionModule': {'briefSummary': 'PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.', 'detailedDescription': "PRO-RCC is designed as a multicenter cohort for all Dutch patients with localized RCC or metastatic renal cell carcinoma (mRCC). The clinical data collection is embedded in the framework of the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. The informed consent for PRO-RCC covers the online collection of PROMs and PREMS, data sharing and data linking with the NCR. PROMS entail Health-Related Quality of Life (HRQoL), and optional return to work- questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Importantly, participants may also consent to participation in a 'Trial within cohort' studies (TwiC). The TwiC design provides a method to perform (randomized) studies within the registry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed patients with RCC or synchronous metastatic RCC\n* metachronous metastasized RCC\n* age \\>18 years\n* capable of understanding Dutch language\n\nExclusion Criteria:\n\n* n/a'}, 'identificationModule': {'nctId': 'NCT05326620', 'acronym': 'PRO-RCC', 'briefTitle': 'National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)', 'organization': {'class': 'OTHER', 'fullName': 'PROspective Renal Cancer Cohort Foundation'}, 'officialTitle': 'PROspective Renal Cancer Cohort (PRO-RCC)', 'orgStudyIdInfo': {'id': '2021_218'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'localized RCC', 'description': 'all patients with localized RCC'}, {'label': 'metastatic RCC', 'description': 'all patients with metastatic RCC, synchronous or metachronous'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'A.D. Bins', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC locatie VUMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': "'s-Hertogenbosch", 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'T Smilde', 'role': 'CONTACT'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': "'s-Hertogenbosch", 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Saskia van der Meer, MD PhD', 'role': 'CONTACT'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Amersfoort', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'JM van Dodewaard', 'role': 'CONTACT'}], 'facility': 'Meander Medisch Centrum', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Apeldoorn', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'D. Bochove', 'role': 'CONTACT'}], 'facility': 'Gelre ziekenhuis', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M. van den Berg', 'role': 'CONTACT'}], 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'H Westgeest', 'role': 'CONTACT'}], 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Deventer', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'A Imholz', 'role': 'CONTACT'}], 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'city': 'Dordrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J. van den Bosch', 'role': 'CONTACT'}], 'facility': 'Albert Schweitzer', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'W Scheepens', 'role': 'CONTACT'}], 'facility': 'Catharina ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M. Dercksen', 'role': 'CONTACT'}], 'facility': 'Maxima MC', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Emmen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'B Knipscheer', 'role': 'CONTACT'}], 'facility': 'Treant', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'S Oosting', 'role': 'CONTACT'}], 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Haarlem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'S Dijkstra', 'role': 'CONTACT'}], 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Hilversum', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'H.P. van den Berg', 'role': 'CONTACT'}], 'facility': 'Tergooi MC', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Leeuwarden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'B Rikhof', 'role': 'CONTACT'}], 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'MJB Essers Aarts', 'role': 'CONTACT'}], 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nieuwegein', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'K Herbschleb', 'role': 'CONTACT'}], 'facility': 'St Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'S Dijkstra', 'role': 'CONTACT'}], 'facility': 'Canisius Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Roosendaal', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'E Collette', 'role': 'CONTACT'}], 'facility': 'Bravis ziekenhuis', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Paul Verhagen', 'role': 'CONTACT'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Haberkorn', 'role': 'CONTACT'}], 'facility': 'Maasstad ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'R Soest', 'role': 'CONTACT'}], 'facility': 'St. Franciscus ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'L. de Vries', 'role': 'CONTACT'}], 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Venray', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Tom Hermans, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Viecuri', 'geoPoint': {'lat': 51.525, 'lon': 5.975}}, {'city': 'Zwolle', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M. Steffens', 'role': 'CONTACT'}], 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'centralContacts': [{'name': 'Hilin Yildirim, MD', 'role': 'CONTACT', 'email': 'h.yildirim@iknl.nl', 'phone': '0031643202583'}], 'overallOfficials': [{'name': 'Adriaan Bins, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PROspective Renal Cancer Cohort Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comprehensive Cancer Centre The Netherlands', 'class': 'OTHER'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Ipsen', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}