*The use of fecal calprotectin in detecting immunotherapy induced colitis and feasibility for the use of immunohistochemical markers in patients receiving checkpoint inhibitors*- a pilot study

Recruiting

• Conditions: colitis; 10017966

• Registration Number: NL-OMON42995
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Age > 18 years
- Starting with anti CTLA-4 antibodies alone or in combination with anti PD-1 antibodies for a malignancy
- Signed informed consent

Exclusion Criteria

There are no exclusion criteria for participation in this study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>1. Fecal calprotectin levels in patients treated with checkpoint inhibitors and<br /><br>correlation with symptoms and extent of endoscopic inflammation<br /><br>2. Type of endoscopic and histological inflammation in patients with colitis<br /><br>3. Differential expression of colonic cytokines<br /><br>4. Risk factors for colitis (age and gender of patients, type of malignancy,<br /><br>type and dose of immunotherapy, history of auto immune disease, baseline fecal<br /><br>calprotectin)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>