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Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis

Primary Purpose

Genito-Urinary Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection(Punch Biopsy)
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Genito-Urinary Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Skin Biopsies

Arm Description

Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection.

Outcomes

Primary Outcome Measures

Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis
Microbial diversity will be estimated by the Shannon Index.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2021
Last Updated
February 28, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04812197
Brief Title
Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
Official Title
A Single Cohort Study to Characterize Differences in Microbial Diversity Between Inflamed and Non-Inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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. III. To characterize the immune cell phenotype in the peripheral blood in patients who have ICI-induced dermatitis. IV. To elucidate any association between the skin microbial diversity and response to immunotherapy, characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (e.g., durable complete response [CR] versus partial response [PR] versus stable disease [SD] versus primary progressive disease). V. To ascertain if higher concentrations of certain bacterial species are associated with a response to immunotherapy, characterized by both RECIST and immune response criteria. VI. To evaluate associations between the non-inflamed skin flora and cancer subtypes (e.g., renal cell carcinoma, bladder cancer, lung cancer). VII. To examine if skin microbiome is associated with specific demographic characteristics such as age and gender. OUTLINE: Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genito-Urinary Neoplasm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin Biopsies
Arm Type
Other
Arm Description
Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection(Punch Biopsy)
Other Intervention Name(s)
Biospecimen Collection (Punch Biopsy)
Intervention Description
Punch Biopsy of Skin
Primary Outcome Measure Information:
Title
Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis
Description
Microbial diversity will be estimated by the Shannon Index.
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Skin microbial diversity
Description
Will be associated with response to therapy. The non-flamed skin of responders versus non-responders will be compared against change in Shannon Index. Both parametric and non-parametric tests will be performed on the data as well as its log-transformation.
Time Frame
Up to 1 year
Title
Abundances of certain skin bacteria in lesion
Description
Will be associated with a higher rate of dermatologic toxicity with ICI. Similar to the evaluation of microbial diversity, will evaluate the concentrations of specific bacteria of inflamed as compared to non-inflamed skin of a similar phenotype (e.g. sebaceous, moist, or dry). This will entail both an individual bacteria abundance evaluation and clustering analysis.
Time Frame
Up to 1 year
Title
Specific skin bacteria
Description
Will be associated with higher response to ICI. Will evaluate specific bacteriomic differences between the responders and non-responders via individual bacteria abundance assessment and clustering analysis. Response will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and assessed at the time of each skin biopsy. This will entail both an individual bacteria abundance evaluation and clustering analysis.
Time Frame
Up to 1 year
Title
Tissue and peripheral immune cell phenotypes of ICI-induced dermatitis (I)
Description
Will use immunohistochemistry to aid in characterizing the dermatologic microenvironment as follows: will use immunohistochemistry to aid in characterizing the dermatologic microenvironment. The Human Cytokine 30-plex protein assay (Invitrogen) will be used to characterize the plasma levels of cytokines in pg/mL.
Time Frame
Up to 1 year
Title
Tissue and peripheral immune cell phenotypes of ICI-induced dermatitis (II)
Description
Will use immunohistochemistry to aid in characterizing the dermatologic microenvironment as follows: will use immunohistochemistry to aid in characterizing the dermatologic microenvironment. Fluorochrome-labeled antibodies will be used to characterize the number of myeloid cells.
Time Frame
Up to 1 year
Title
Tissue and peripheral immune cell phenotypes of ICI-induced dermatitis (III)
Description
Will use immunohistochemistry to aid in characterizing the dermatologic microenvironment as follows: will use immunohistochemistry to aid in characterizing the dermatologic microenvironment. EasySep PE-selection kit will be used to characterize the number of T cells.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumanta K Pal
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis

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