How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

Immunotherapy Multi-omics Specimen Protocol A

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03370861

Acronym

MINING

Enrollment

Registered

2017-12-12

Start date

2017-11-08

Completion date

2022-12-31

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALImmunotherapy

Medications that increase the activity of the immune system.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Overall Survival	2 years	Overall Survival

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026