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Exploration of Biomarker Clusters for Immune-Related Skin Adverse Events in Urological Tumors

Exploration of Biomarker Clusters for Immune-Related Skin Adverse Events in Urological Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111508
Enrollment
Unknown
Registered
2025-10-31
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

tumors of the genitourinary system

Interventions

Skin lesion group:none
Control group:none

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the Dermatitis Group (D Group): (1) A confirmed diagnosis of advanced RCC or UC and having received at least one cycle of ICI treatment during the study; (2) A clear diagnosis of immune-related skin adverse events confirmed jointly by dermatologists and urologists; (3) Adults aged 18-75 years. 2. Inclusion criteria for the Control Group (N Group): (1) A confirmed diagnosis of advanced RCC or UC and having received at least one cycle of ICI treatment during the study;(2) Clinically confirmed by physicians during follow-up that no immune-related skin adverse events occurred; (3) Adults aged 18-75 years.

Exclusion criteria

Exclusion criteria: 1. Patients with active, uncontrolled skin diseases (such as psoriasis or acute eczema) at the start of ICI therapy; 2. Pregnant patients; 3. Patients under 18 years old and over 75 years old; 4. Patients who are hemodynamically unstable; 5. Patients who have used systemic immunosuppressants (such as glucocorticoids, except for prophylactic use or for non-autoimmune conditions) within 4 weeks before ICI therapy; 6. Other situations that may confound the assessment of dermatitis, such as a clear history of other drug allergies, rashes caused by active infections, and dermatitis caused by other medications; 7. Patients unwilling to participate in the study; 8. Patients with incomplete clinical data (medical records and test results, etc.).

Design outcomes

Primary

MeasureTime frame
General information of the patient (including age, gender, height, weight, BMI);Blood biochemical indicators;Complete blood count indicators;

Secondary

MeasureTime frame
Urinalysis indicators;

Countries

China

Contacts

Public ContactXiao Jing

Beijing Friendship Hospital ,Capital Medical University

doctorxiao2006@163.com+86 10 8083 8775

Outcome results

None listed

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