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.
ID
Bron
Verkorte titel
Aandoening
colitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in fecal calprotectin levels in relation to severity of endoscopic colitis
Achtergrond van het onderzoek
Primary: To determine fecal calprotectin levels in patients treated with checkpoint inhibitors.
Doel van het onderzoek
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.
Onderzoeksopzet
study will be completed if 8 patients with colitis will be included in the study
Onderzoeksproduct en/of interventie
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
Publiek
J. van Dieren
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
Tel +31-20-5129111
Email: j.v.dieren@nki.nl
Wetenschappelijk
J. van Dieren
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
Tel +31-20-5129111
Email: j.v.dieren@nki.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age > 18 years
- Starting with anti CTLA-4 antibodies alone or in combination with anti PD-1 antibodies for a malignancy
- Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
There are no exclusion criteria for participation in this study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5660 |
NTR-old | NTR5795 |
CCMO | NL56864.031.16 |
OMON | NL-OMON42995 |