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NCT03370861 Clinical Trial

How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

Melanoma Clinical Trial

— MINING  

Official title:
Immunotherapy Multi-omics Specimen Protocol A

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03370861
Other study ID # MINING
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2017
Est. completion date December 31, 2022

Study information
Verified date January 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 125
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: - Bowel resection. - Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Immunotherapy
Medications that increase the activity of the immune system.

Locations
Country Name City State
United States Barnes-Jewish Hosptial Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune-related Adverse Events (irAEs) 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. 2 years
Secondary Overall Survival Overall Survival 2 years
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