German National Registry for NSS

Kidney Neoplasm Clinical Trial

Official title:

German National Registry for Nephron-Sparing Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04681690
• Other study ID #: G-NeSS
• Status: Not yet recruiting
• Start date: December 15, 2020
• Est. completion date: September 15, 2027

Study information

• Verified date: December 2020
• Source: Association of Urologic Oncology (AUO)
• Contact: Nina Harke, Dr.
• Phone: 0511/532
• Email: harke.nina[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasm
• Kidney Neoplasms

Intervention

Other:
• No intervention, observation only.
Observation only

Locations

Country	Name	City	State
Germany	Vivantes Humboldt Klinikum	Berlin
Germany	MHH	Hannover	Niedersachsen
Germany	Saarland University	Homburg/Saar

Sponsors (2)

Lead Sponsor	Collaborator
Association of Urologic Oncology (AUO)	IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Complication rate according to Clavien-Dindo in %	60 months
Primary	Postoperative glomerular inflitration rate	Rate in ml/min.	60 months
Primary	Survival	Overall Survival	60 months