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

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ClinicalTrials.gov Identifier: NCT03370861
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : June 25, 2018
Sponsor:
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, 2020
Estimated Study Completion Date : December 31, 2020



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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03370861


Locations
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United States, Missouri
Barnes-Jewish Hosptial Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Research Study Coordinator    314-362-1000    rprstaff@wusm.wustl.edu   
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
ClinicalTrials.gov Identifier: NCT03370861     History of Changes
Other Study ID Numbers: MINING
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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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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Immunologic Factors
Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Skin Neoplasms
Autoimmune Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Immune System Diseases
Physiological Effects of Drugs