German National Registry for NSS

NCT ID: NCT04681690

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-15

Study Completion Date

2027-09-15

Brief Summary

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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

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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

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Kidney Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention, observation only.

Observation only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IAG-N at German Cancer Association (Deutsche Krebsgesellschaft e. V.)

UNKNOWN

Sponsor Role collaborator

Association of Urologic Oncology (AUO)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina Harke, Dr.

Role: STUDY_CHAIR

MHH

Stefan Siemer, Prof. Dr.

Role: STUDY_CHAIR

University Saarland

Steffen Weikert, Prof. Dr.

Role: STUDY_CHAIR

Vivantes Humboldt-Klinikum

Locations

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Sana Klinikum Hof

Hof, Bavaria, Germany

Site Status RECRUITING

MHH

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Alexianer St. Hedwig-Krankenhaus

Berlin, , Germany

Site Status RECRUITING

Vivantes Humboldt Klinikum

Berlin, , Germany

Site Status RECRUITING

Saarland University

Homburg/Saar, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Nina Harke, Dr.

Role: CONTACT

0511/532 ext. 36 47

Heidrun Rexer

Role: CONTACT

039827/79 677

Facility Contacts

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Abhishek Pandey, Dr.

Role: primary

Nina Harke, Dr.

Role: primary

0511/532- ext. 36 47

Steffen Weikert, Prof. Dr.

Role: primary

Steffen Weikert, Prof. Dr.

Role: primary

030/130 12-12 91

Stefan Siemer, Prof. Dr.

Role: primary

+49-(0)6841-1624702

Other Identifiers

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G-NeSS

Identifier Type: -

Identifier Source: org_study_id

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