How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

NCT03370861 | Terminated FDA Drug

• 1 other identifier: MINING
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  2 years

Interventions

Immunotherapy BIOLOGICAL

Medications that increase the activity of the immune system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with skin cancer planning to initiate or already on ANY type of immunotherapy.

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hosptial

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Urine

MeSH Terms

Conditions

Autoimmune Diseases; Melanoma; Carcinoma, Merkel Cell; Carcinoma, Basal Cell; Skin Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• William H McCoy IV, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor of Medicine

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: November 8, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

US (1)