How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

• Conditions: Merkel Cell Carcinoma; Skin Cancer; Squamous Cell Carcinoma of the Skin; Autoimmunity; Melanoma; Basal Cell Carcinoma

• Registration Number: NCT03370861
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

Detailed Description

Details will be available upon publication.

Study Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• ≥18 years of age.
• Diagnosis of skin cancer.
• Planning to initiate or already on ANY type of immunotherapy.
• Able to provide urine and stool specimens.

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Exclusion Criteria

• Bowel resection.
• Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune-related Adverse Events (irAEs)	2 years	Electronic medical records will be queried for specific drug-related adverse events known as immune-related Adverse Events (irAEs) including but not limited to colitis, hypophysitis, hepatitis, pneumonitis, pancreatitis, arthritis, rash, and vitiligo.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years	Overall Survival

Trial Locations

Locations (1)

Barnes-Jewish Hosptial; 🇺🇸 Saint Louis, Missouri, United States