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How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes (MINING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03370861
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : October 4, 2019
Information provided by (Responsible Party):
William H. McCoy IV, MD, PhD, 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.

Condition or disease Intervention/treatment
Autoimmunity Melanoma Merkel Cell Carcinoma Squamous Cell Carcinoma of the Skin Basal Cell Carcinoma Skin Cancer Biological: Immunotherapy

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunotherapy Multi-omics Specimen Protocol A
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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

Primary Outcome Measures :
  1. Immune-related Adverse Events (irAEs) [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: 2 years ]
    Overall Survival

Biospecimen Retention:   Samples With DNA
Stool, Urine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with skin cancer planning to initiate or already on ANY type of immunotherapy.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03370861

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United States, Missouri
Barnes-Jewish Hosptial Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Research Study Coordinator    314-362-1000   
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: William H. McCoy IV, MD, PhD, Research Instructor of Medicine, Washington University School of Medicine Identifier: NCT03370861    
Other Study ID Numbers: MINING
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine