NCT04812197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 25, 2021

Last Update Submit

February 28, 2023

Conditions

Genito-Urinary Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis

    Microbial diversity will be estimated by the Shannon Index.

    Up to 1 year

Other Outcomes (6)

  • Skin microbial diversity

    Up to 1 year

  • Abundances of certain skin bacteria in lesion

    Up to 1 year

  • Specific skin bacteria

    Up to 1 year

  • +3 more other outcomes

Study Arms (1)

Skin Biopsies

OTHER

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

Procedure: Biospecimen Collection(Punch Biopsy)

Interventions

Biospecimen Collection(Punch Biopsy)PROCEDURE

Punch Biopsy of Skin

Also known as: Biospecimen Collection (Punch Biopsy)
Skin Biopsies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Urogenital Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sumanta K Pal

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 23, 2021

Study Start

March 8, 2021

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

US(1)