Kidney NeoplasmNCT04681690
German National Registry for NSS
An observational study of Kidney Neoplasm, run by Association of Urologic Oncology (AUO) at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Neoplasm
- How many people
- 137 participants
- Where
- 5 sitesGermany
- Study dates
- 15 Dec 2020to 31 Dec 2025
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a renal mass eligible for partial nephrectomy
Who may be able to join
- 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)
Who cannot join
- Patient with (or suspected to have) urothelial cancer of the kidney
- Prior nephron-sparing surgery on ipsilateral kidney
- metastasized renal cell carcinoma
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Vivantes Humboldt Klinikum
Berlin, State of Berlin
Alexianer St. Hedwig-Krankenhaus
Berlin, 10115
MHH
Hanover, Lower Saxony, 30625
Sana Klinikum Hof
Hof, Bavaria, 95032
Saarland University
Homburg/Saar, 66421
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Neoplasm
- Being tested
- No intervention, observation only.
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observation only.Other
Observation only
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Complication rate according to Clavien-Dindo in %
Measured: 60 months
Postoperative glomerular inflitration rate
Rate in ml/min.
Measured: 60 months
Survival
Overall Survival
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start15 Dec 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Association of Urologic Oncology (AUO)
- Sponsor type
- University, hospital or other
- Collaborators
- IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
- Responsible party
- Sponsor
- Investigators
- Nina Harke, Dr., Study chair, MHHStefan Siemer, Prof. Dr., Study chair, University SaarlandSteffen Weikert, Prof. Dr., Study chair, Vivantes Humboldt-Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681690
- Sponsor's protocol ID
- G-NeSS
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German National Registry for Nephron-Sparing Surgery
- ClinicalTrials.gov ID
- NCT04681690
- Acronym / sponsor ID
- G-NeSS
- Conditions
- Kidney Neoplasm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of financial support
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Association of Urologic Oncology (AUO)University, hospital or other
- Collaborators
- IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a renal mass eligible for partial nephrectomy
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Patient with (or suspected to have) urothelial cancer of the kidney
- Prior nephron-sparing surgery on ipsilateral kidney
- metastasized renal cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observation only.Observation only | Other | – |
Primary outcome
Complication rate
Time frame: 60 months
Complication rate according to Clavien-Dindo in %
Postoperative glomerular inflitration rate
Time frame: 60 months
Rate in ml/min.
Survival
Time frame: 60 months
Overall Survival
Results and safety
The study was stopped early (reason given: Lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Harke, Dr. study chair
MHH
Stefan Siemer, Prof. Dr. study chair
University Saarland
Steffen Weikert, Prof. Dr. study chair
Vivantes Humboldt-Klinikum
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasm, run by Association of Urologic Oncology (AUO) at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.