Identification of predictive parameters for colitis in melanoma patients treated with immunotherapy.

Identification of predictive parameters for colitis in melanoma patients treated with immunotherapy. - Biomarkers for immunotherapy-induced colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41415

Enrollment

300

Registered

2012-09-04

Start date

2013-08-16

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. patients with melanoma who will be treated with immunotherapy 2. signed written informed consent 3. able to comply with the protocol

Exclusion criteria

Exclusion criteria: 1. patients with a pre-existing colitis (e.g. Crohn*s disease, ulcerative colitis)

Design outcomes

Primary

Measure	Time frame
- DNA profile to identify genetic risk factors in 10 mL EDTA. - Colitis based on clinical symptomatology, sigmoidoscopy, pathological findings from biopsies and immunological tests in those biopsies. - Defining the severity of epithelial dysfunction measured with MAYO score and BRISTOL stool scale, the measurement of calprotectin level and microbiome composition in the stool and serum IL-8, citrullin, FABP, calprotectin, endotoxin and CRP levels during visits to the outpatient clinic.	—

Measure

Time frame

- DNA profile to identify genetic risk factors in 10 mL EDTA. - Colitis based on clinical symptomatology, sigmoidoscopy, pathological findings from biopsies and immunological tests in those biopsies. - Defining the severity of epithelial dysfunction measured with MAYO score and BRISTOL stool scale, the measurement of calprotectin level and microbiome composition in the stool and serum IL-8, citrullin, FABP, calprotectin, endotoxin and CRP levels during visits to the outpatient clinic.

—

Secondary

Measure	Time frame
A simple, cheap, diagnostic test will be developed using these data which can be rapidly adopted in clinical practice (e.g. calprotectin level in the stool or serum IL-8, citrullin, FABP, calprotectin, endotoxin and CRP-levels, or a combination).	—

Countries

Netherlands

Outcome results