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JOURNAL ONKOLOGIE – STUDIE

German National Registry for NSS

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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

Nina Harke, Dr.
Study Chair
MHH
Stefan Siemer, Prof. Dr.
Study Chair
University Saarland
Steffen Weikert, Prof. Dr.
Study Chair
Vivantes Humboldt-Klinikum

Kontakt

Studienlocations (3 von 3)

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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