Status:
COMPLETED
Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Genito-Urinary Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 im...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04812197
Start Date
March 8 2021
End Date
October 8 2021
Last Update
March 1 2023
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010