Identification of predictive parameters for colitis in melanoma patients treated with immunotherapy.

Completed

• Conditions: melanoma; skin cancer; 10040900

• Registration Number: NL-OMON41415
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. patients with melanoma who will be treated with immunotherapy
2. signed written informed consent
3. able to comply with the protocol

Exclusion Criteria

1. patients with a pre-existing colitis (e.g. Crohn*s disease, ulcerative colitis)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- DNA profile to identify genetic risk factors in 10 mL EDTA.<br /><br>- Colitis based on clinical symptomatology, sigmoidoscopy, pathological<br /><br>findings from biopsies and immunological tests in those biopsies.<br /><br>- Defining the severity of epithelial dysfunction measured with MAYO score and<br /><br>BRISTOL stool scale, the measurement of calprotectin level and microbiome<br /><br>composition in the stool and serum IL-8, citrullin, FABP, calprotectin,<br /><br>endotoxin and CRP levels during visits to the outpatient clinic.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A simple, cheap, diagnostic test will be developed using these data which can<br /><br>be rapidly adopted in clinical practice (e.g. calprotectin level in the stool<br /><br>or serum IL-8, citrullin, FABP, calprotectin, endotoxin and CRP-levels, or a<br /><br>combination).</p><br>