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German National Registry for NSS

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ClinicalTrials.gov Identifier: NCT04681690
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
Information provided by (Responsible Party):
Association of Urologic Oncology (AUO)

Study Description
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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.

Condition or disease Intervention/treatment
Kidney Neoplasm 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: German National Registry for Nephron-Sparing Surgery
Estimated Study Start Date : December 15, 2020
Estimated Primary Completion Date : September 15, 2026
Estimated Study Completion Date : September 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Groups and Cohorts
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Intervention Details:
  • Other: No intervention, observation only.
    Observation only

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a renal mass eligible for partial nephrectomy
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681690


Contacts
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Contact: Nina Harke, Dr. 0511/532 ext 36 47 harke.nina@mh-hannover.de
Contact: Heidrun Rexer 039827/79 677 GNeSS@MeckEvidence.de

Locations
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Germany
MHH
Hannover, Niedersachsen, Germany, 30625
Contact: Nina Harke, Dr.    0511/532- ext 36 47    harke.nina@mh-hannover.de   
Principal Investigator: Nina Harke, Dr.         
Vivantes Humboldt Klinikum
Berlin, Germany
Contact: Steffen Weikert, Prof. Dr.    030/130 12-12 91    Steffen.Weikert@vivantes.de   
Principal Investigator: Steffen Weikert, Prof. Dr.         
Saarland University
Homburg/Saar, Germany, 66421
Contact: Stefan Siemer, Prof. Dr.    +49-(0)6841-1624702    stefan.siemer@uks.eu   
Principal Investigator: Stefan Siemer, Prof. Dr.         
Sponsors and Collaborators
Association of Urologic Oncology (AUO)
IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
Investigators
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Study Chair: Nina Harke, Dr. MHH
Study Chair: Stefan Siemer, Prof. Dr. University Saarland
Study Chair: Steffen Weikert, Prof. Dr. Vivantes Humboldt-Klinikum
More Information
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Responsible Party: Association of Urologic Oncology (AUO)
ClinicalTrials.gov Identifier: NCT04681690    
Other Study ID Numbers: G-NeSS
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Kidney Diseases
Urologic Diseases