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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25248

Enrollment

Registered

2016-02-24

Start date

2016-04-04

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colitis

Interventions

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 wee

Eligibility

Inclusion criteria

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

Exclusion criteria: There are no exclusion criteria for participation in this study.

Design outcomes

Primary

Measure	Time frame
Difference in fecal calprotectin levels in relation to severity of endoscopic colitis	—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Contacts

Public ContactJ. van Dieren

NKI-AVL, Amsterdam - Department of Gastroenterology

Email: j.v.dieren@nki.nlTel +31-20-5129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)