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GUARDIANS-Registry (GenitoUrinary Academic Research Development Initiative and Network)

GUARDIANS-Registry (GenitoUrinary Academic Research Development Initiative and Network) - GUARDIANS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038253
Enrollment
500
Registered
2025-10-28
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C60 C61 C62 C63 C64 C65 C66 C67 C68

Interventions

Group 1: Patients with genitourinary malignancies (e.g., urothelial carcinoma, renal cell carcinoma) receiving systemic therapy (such as immunotherapy, chemotherapy, or targeted therapy) as part of ro
all treatments are determined by the treating physician according to standard of care.

Sponsors

Urologische Klinik und Poliklinik, LMU Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of a genitourinary malignancy (ICD C60–C68), including prostate, urothelial, kidney, penile, or testicular cancer Received systemic therapy (e.g., chemotherapy, immunotherapy, targeted therapy, antibody-drug conjugates, or anti-hormonal therapy) Treatment and documentation at a participating university or tertiary care center Availability of sufficient clinical documentation according to the inclusion criteria

Exclusion criteria

Exclusion criteria: Incomplete or inconsistent clinical data Missing essential treatment or follow-up information

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS), defined as the time from initiation of systemic therapy to the first documented disease progression (as assessed by the treating physician according to RECIST 1.1) or death from any cause, whichever occurs first.

Secondary

MeasureTime frame
Overall Survival (OS) Cancer-Specific Survival (CSS) Recurrence-Free Survival (RFS) Objective Response Rate (ORR) Treatment duration, line, sequence, and dose modifications during systemic therapy Treatment discontinuation and reasons for discontinuation Treatment tolerability and adverse event profile graded according to CTCAE version 5.0

Countries

Austria, Germany, Switzerland

Contacts

Public ContactJozefina Casuscelli

Urologische Klinik und Poliklinik, LMU Klinikum

jozefina.casuscelli@med.uni-muenchen.de+498944000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026