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


- candidate number24016
- NTR NumberNTR5795
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2016
- Secondary IDsNL56864.031.16 
- Public TitleThe use of fecal calprotectin in detecting immunotherapy induced colitis and feasibility for the use of immunohistochemical markers in patients receiving checkpoint inhibitorsí- a pilot study
- Scientific TitleThe use of fecal calprotectin in detecting immunotherapy induced colitis and feasibility for the use of immunohistochemical markers in patients receiving checkpoint inhibitorsí- a pilot study
- ACRONYMCOLIT-1
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedUlcerative Colitis
- 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 criteriaThere are no exclusion criteria for participation in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-apr-2016
- planned closingdate9-sep-2016
- Target number of participants50
- InterventionsParticipants 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
- Primary outcomeDifference 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
- Timepointsstudy will be completed if 8 patients with colitis will be included in the study
- Trial web siten.a.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr J. van Dieren
- CONTACT for SCIENTIFIC QUERIESdr J. van Dieren
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- Publications
- Brief summaryPrimary: To determine fecal calprotectin levels in patients treated with checkpoint inhibitors.
- Main changes (audit trail)
- RECORD24-feb-2016 - 30-mei-2016


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