NCT04681690

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2020Sep 2027

First Submitted

Initial submission to the registry

September 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

5.8 years

First QC Date

September 9, 2020

Last Update Submit

January 27, 2025

Conditions

Kidney Neoplasm

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

No intervention, observation only.OTHER

Observation only

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a renal mass eligible for partial nephrectomy

You may qualify if:

  • 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)

You may not qualify if:

  • Patient with (or suspected to have) urothelial cancer of the kidney
  • Prior nephron-sparing surgery on ipsilateral kidney
  • metastasized renal cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sana Klinikum Hof

Hof, Bavaria, 95032, Germany

RECRUITING

MHH

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Alexianer St. Hedwig-Krankenhaus

Berlin, 10115, Germany

RECRUITING

Vivantes Humboldt Klinikum

Berlin, Germany

RECRUITING

Saarland University

Homburg/Saar, 66421, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Nina Harke, Dr.

    MHH

    STUDY CHAIR

  • Stefan Siemer, Prof. Dr.

    University Saarland

    STUDY CHAIR

  • Steffen Weikert, Prof. Dr.

    Vivantes Humboldt-Klinikum

    STUDY CHAIR

Central Study Contacts

Nina Harke, Dr.

CONTACT

0511/532harke.nina@mh-hannover.de

Heidrun Rexer

CONTACT

039827/79 677GNeSS@MeckEvidence.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

December 23, 2020

Study Start

December 15, 2020

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2027

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

DE(5)