To identify predictive parameters for colitis in melanoma patients treated with immunotherapy
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
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).
Background summary
Immunotherapy is an interesting treatment option for patients with metastatic
melanoma. However, in about 10% of patients treated with immunotherapy a grade
3-4 colitis will occur. We want to find a good predictive biomarker to select
patients that are prone to grade 3-4 colitis.
Study objective
To identify predictive parameters for colitis in melanoma patients treated with
immunotherapy
Study design
It will be a pilot study in which melanoma patients treated with immunotherapy
will be followed during treatment. It consists of three parts: 1.) to identify
a genetic profile associated with immunotherapy-induced colitis, 2.) to
identify predictive biomakers for immunotherapy-induced colitis and 3.) to
study the tissue of immunotherapy-induced colitis. Patients are able to
participate in one, two or all parts of the study.
Study burden and risks
Patients have no direct benefit from participation in this study.
Risks:
- Blood samples will be collected for biomarkers every regular visit, and DNA
isolation at baseline.
- Patients collect stool at home and store in in a freezer until it is picked
up at home
- During sigmoidoscopy in case of suspect colitis, additional biopsies are
optional.
- A daily stool diaty is filled in
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
1. patients with a pre-existing colitis (e.g. Crohn*s disease, ulcerative colitis)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39845.042.12 |