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JOURNAL ONKOLOGIE – STUDIE
German National Registry for NSS
Noch nicht rekrutierend
NCT-Nummer:
NCT04681690
Studienbeginn:
Dezember 2020
Letztes Update:
23.12.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Kidney Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Association of Urologic Oncology (AUO)
Collaborator:
IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
Studienleiter
Study Chair
MHH
Study Chair
University Saarland
Study Chair
Vivantes Humboldt-Klinikum
Kontakt
Kontakt:
Phone: 0511/532
Phone (ext.): 36 47
E-Mail: harke.nina@mh-hannover.de» Kontaktdaten anzeigen
Kontakt:
Phone: 039827/79 677
E-Mail: GNeSS@MeckEvidence.de» Kontaktdaten anzeigen
Studienlocations
(3 von 3)
30625 Hannover
(Niedersachsen)
Germany» Google-Maps
Ansprechpartner:
Nina Harke, Dr.
Phone: 0511/532-
Phone (ext.): 36 47
E-Mail: harke.nina@mh-hannover.de» Ansprechpartner anzeigen
Berlin
(Berlin)
Germany» Google-Maps
Ansprechpartner:
Steffen Weikert, Prof. Dr.
Phone: 030/130 12-12 91
E-Mail: Steffen.Weikert@vivantes.de» Ansprechpartner anzeigen
66421 Homburg/Saar
(Saarland)
Germany» Google-Maps
Ansprechpartner:
Stefan Siemer, Prof. Dr.
Phone: +49-(0)6841-1624702
E-Mail: stefan.siemer@uks.eu» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:Today the majority of patients with renal tumors is diagnosed with localized disease amenable
to nephron-sparing surgery (NSS). Partial nephrectomy (PN) constitutes the reference standard
treatment for small renal masses according to international guidelines. Open PN ist still the
predominant apporach in Germany, but the use of minimally-invasive surgery has continously
increased over the last decades. Specifically, robotic surgery is on the rise and may
facilitate the adoption of a minimally-invasive PN approach even in more complex renal
tumours. Real world data on the outcomes of PN according to the surgical approach are
limited. Data from cancer registries and health insurance databases usually lack important
information an key patient und tumour characteristics, such as tumour complexity.
The G-NESS registry database aims at prospectively collecting such clinical and outcome data
from patients undergoing PN. Data collection includes perioperative variables on patient
characteristics, tumour location and complexity, surgical approach, intra-/postoperative
complications, and kidney function. Follow-up based on questionnaires is conducted after
predefined intervals (i.e. 30 days, 12 months, 24 months, and 60 months) in order to receive
information on long-term kidney function, comorbidities, and survival. The information
received from the database can help to better define the optimal surgical care for patients
with renal masses.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Age ≥ 18 years
- Written informed consent
- Localized renal parenchymal mass amenable to nephron-sparing surgery
- Adequate imaging of the abdomen (CT or MR with contrast)
Exclusion Criteria:
- Patient with (or suspected to have) urothelial cancer of the kidney
- Prior nephron-sparing surgery on ipsilateral kidney
- metastasized renal cell carcinoma
Studien-Rationale
Primary outcome:1. Complication rate (Time Frame - 60 months):
Complication rate according to Clavien-Dindo in %
2. Postoperative glomerular inflitration rate (Time Frame - 60 months):
Rate in ml/min.
3. Survival (Time Frame - 60 months):
Overall Survival
Geprüfte Regime
- No intervention, observation only.:
Observation only
Quelle: ClinicalTrials.gov
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