No registrations found.
ID
Source
Brief title
Health condition
colitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in fecal calprotectin levels in relation to severity of endoscopic colitis
Secondary outcome
- Difference in mucosal regulatory foxp3+ T cells and their expression of cytokine profiles between patients with and without colitis
- Endoscopic and histologic findings in patients with colitis in both affected and non-affected mucosa.
- Risk factors for developing immunotherapy induced colitis
- Age and gender of patients;
- Type of malignancy;
- Type and dose of immunotherapy (and combination with other anti-cancer therapy);
- history of auto immune disease;
- baseline fecal calprotectin
- The correlation between complaints, fecal calprotectin levels and endoscopic image
- interval between start checkpoint inhibitors and symptoms
- presence of gastrointestinal symptoms (diarrhea, mucus or blood in stool, abdominal pain)
- complications of colitis (perforation, death)
- other irAEs
Background summary
Primary: To determine fecal calprotectin levels in patients treated with checkpoint inhibitors.
Study objective
To analyse whether fecal calprotectin is a useful marker in distinguishing colitis from diarrhoea with other causes and whether fecal calprotectin is a useful marker for early detection of colitis.
Study design
study will be completed if 8 patients with colitis will be included in the study
Intervention
Participants are asked to collect feces every two or three weeks (depending on the interval of the administration of the immunotherapy) starting prior to the first cycle of immunotherapy until 2-3 weeks after the last cycle. They will be questioned every 2-3 weeks (either during regular visits or by means of a telephone call) about gastro-intestinal symptoms.
If patients experience gastrointestinal symptoms which may indicate colitis a colonoscopy with at least 10 biopsies will be performed
J. van Dieren
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
Tel +31-20-5129111
Email: j.v.dieren@nki.nl
J. van Dieren
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
Tel +31-20-5129111
Email: j.v.dieren@nki.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5660 |
| NTR-old | NTR5795 |
| CCMO | NL56864.031.16 |
| OMON | NL-OMON42995 |