A Single Cohort Study to Characterize Differences in Microbial Diversity Between Inflamed and Non-Inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis
Study Overview
Brief Summary
This study determines microbial diversity between inflamed and non-inflamed skin of patients with immune checkpoint inhibitor-induced dermatitis. Skin has millions of bacteria. When treated with an immunotherapy agent, skin issues like a rash are common, occurring in up to 45% of patients. This study finds out if the type of bacteria on skin is different between the affected and unaffected skin in patients who have this treatment-related rash and also compares the immune cells found in the skin tissue to those seen in the blood.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine if skin microbial diversity (estimated by the Shannon Index) significantly differs between inflamed and non-inflamed skin from patients who have immune checkpoint inhibitor (ICI)-induced dermatitis.
SECONDARY OBJECTIVES:
I. To investigate if certain bacterial species and strains are present in higher concentrations of inflamed versus non-inflamed skin of patients with ICI-induced dermatitis.
II. To compare the immune cell phenotypes of inflamed and non-inflamed skin from patients who have ICI-induced dermatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination thereof
- •Patients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced dermatitis as part of routine and standard clinical care are eligible
- •Patients must be age 18 or older
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •Measurable disease as per RECIST 1.1
- •Patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible
Exclusion Criteria
- •Patients taking antibiotics or who plan to begin taking antibiotics
- •Use of topical or systemic steroids within the past 14 days. Inhaled steroids are permitted
- •Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results
- •Not recovered to non-dermatologic =< grade 1 toxicities related to any prior therapy
- •Pregnant woman will not be enrolled in this study. It is a regulatory requirement that for studies that carry no prospect of benefit to the woman, the research can only enroll pregnant women if the resulting knowledge cannot be obtained by any other means. In this study, there is no prospect of direct benefit to the pregnant women
- •Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded from this study
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)
Arms & Interventions
Skin Biopsies
Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection.
Intervention: Biospecimen Collection(Punch Biopsy) (Procedure)
Outcomes
Primary Outcomes
Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis
Time Frame: Up to 1 year
Microbial diversity will be estimated by the Shannon Index.
Secondary Outcomes
No secondary outcomes reported