Clinical trial NCT04681690: German National Registry for NSS
Official title: German National Registry for Nephron-Sparing Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Neoplasm
Lead sponsor: Association of Urologic Oncology (AUO)
Sponsor class: OTHER
Collaborators: name: IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
First posted: 2020-12-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a renal mass eligible for partial nephrectomy

Brief summary: The G-NeSS Registry prospectively collects data on clinical and outcome variables from patients undergoing partial nephrectomy for renal masses. Analyses of data aims at identifying key factors determining the quality of surgical care in this patient population.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: 60 months
measure: Postoperative glomerular inflitration rate
timeFrame: 60 months
measure: Survival
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hof
country: Germany
facility: Sana Klinikum Hof
state: Bavaria
city: Hannover
country: Germany
facility: MHH
state: Niedersachsen
city: Berlin
country: Germany
facility: Alexianer St. Hedwig-Krankenhaus
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Homburg/Saar
country: Germany
facility: Saarland University
Study officials:
affiliation: MHH
name: Nina Harke, Dr.
role: STUDY_CHAIR
affiliation: University Saarland
name: Stefan Siemer, Prof. Dr.
role: STUDY_CHAIR
affiliation: Vivantes Humboldt-Klinikum
name: Steffen Weikert, Prof. Dr.
role: STUDY_CHAIR
References: