German National Registry for NSS

German National Registry for Nephron-Sparing Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Neoplasm
• Intervention / Treatment: Other: No intervention, observation only.

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Nina Harke, Dr.; Phone Number: 36 47 0511/532; Email: harke.nina@mh-hannover.de
• Study Contact Backup: Name: Heidrun Rexer; Phone Number: 039827/79 677; Email: GNeSS@MeckEvidence.de

Study Locations

• Germany
  • Berlin, Germany
    • Vivantes Humboldt Klinikum
    • Contact: Steffen Weikert, Prof. Dr.; Phone Number: 030/130 12-12 91; Email: Steffen.Weikert@vivantes.de
    • Principal Investigator: Steffen Weikert, Prof. Dr.
  • Homburg/Saar, Germany, 66421
    • Saarland University
    • Contact: Stefan Siemer, Prof. Dr.; Phone Number: +49-(0)6841-1624702; Email: stefan.siemer@uks.eu
    • Principal Investigator: Stefan Siemer, Prof. Dr.
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • MHH
      • Contact: Nina Harke, Dr.; Phone Number: 36 47 0511/532-; Email: harke.nina@mh-hannover.de
      • Principal Investigator: Nina Harke, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a renal mass eligible for partial nephrectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Complication rate according to Clavien-Dindo in %	60 months
Postoperative glomerular inflitration rate	Rate in ml/min.	60 months
Survival	Overall Survival	60 months

Collaborators and Investigators

• Sponsor: Association of Urologic Oncology (AUO)
• Collaborators: IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
• Investigators: Study Chair: Nina Harke, Dr., MHH; Study Chair: Stefan Siemer, Prof. Dr., University Saarland; Study Chair: Steffen Weikert, Prof. Dr., Vivantes Humboldt-Klinikum

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2020
• Primary Completion (Anticipated): September 15, 2026
• Study Completion (Anticipated): September 15, 2027

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: G-NeSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No