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
- Registration Number
- NL-OMON25248
- Lead Sponsor
- KI-AV
- Brief Summary
Not available
- Detailed Description
Not available
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
Exclusion Criteria
There are no exclusion criteria for participation in this study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in fecal calprotectin levels in relation to severity of endoscopic colitis
- Secondary Outcome Measures
Name Time Method - Difference in mucosal regulatory foxp3+ T cells and their expression of cytokine profiles between patients with and without colitis<br /><br>- Endoscopic and histologic findings in patients with colitis in both affected and non-affected mucosa.<br /><br>- Risk factors for developing immunotherapy induced colitis<br /><br>- Age and gender of patients;<br /><br>- Type of malignancy;<br /><br>- Type and dose of immunotherapy (and combination with other anti-cancer therapy);<br /><br>- history of auto immune disease;<br /><br>- baseline fecal calprotectin<br /><br>- The correlation between complaints, fecal calprotectin levels and endoscopic image<br /><br>- interval between start checkpoint inhibitors and symptoms<br><br />- presence of gastrointestinal symptoms (diarrhea, mucus or blood in stool, abdominal pain)<br /><br>- complications of colitis (perforation, death)<br /><br>- other irAEs