Genito-Urinary NeoplasmNCT04812197
Microbial Diversity Between Inflamed and Non-inflamed Skin of Patients With Immune Checkpoint Inhibitor-Induced Dermatitis
A study testing Biospecimen Collection(Punch Biopsy) in people with Genito-Urinary Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genito-Urinary Neoplasm
- What is being tested?
- Biospecimen Collection(Punch Biopsy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 8 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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).
- 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.
- Conditions
- Genito-Urinary Neoplasm
- Being tested
- Biospecimen Collection(Punch Biopsy)
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen Collection(Punch Biopsy)Procedure or surgery
Also called Biospecimen Collection (Punch Biopsy)
Punch Biopsy of Skin
| Study group | Role | What they receive |
|---|---|---|
| Skin Biopsies | Other | Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection. Receives: Procedure: Biospecimen Collection(Punch Biopsy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis
Microbial diversity will be estimated by the Shannon Index.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start8 Mar 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genito-Urinary NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta K Pal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812197
- Sponsor's protocol ID
- 20378
- Other IDs
- NCI-2021-00221, 20378, P30CA033572
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04812197
- Acronym / sponsor ID
- 20378
- Conditions
- Genito-Urinary Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Biopsies | Other | Procedure: Biospecimen Collection(Punch Biopsy)Patients undergo punch biopsies of inflamed and non-inflamed skin and a blood sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen Collection(Punch Biopsy)Also: Biospecimen Collection (Punch Biopsy)Punch Biopsy of Skin | Procedure or surgery | Skin Biopsies |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumanta K Pal principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection(Punch Biopsy) in people with Genito-Urinary Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between skin microbial diversity and immune checkpoint inhibitor (ICI)-induced dermatitis (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.