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Clinical Trials/NCT04099446
NCT04099446
Withdrawn
Not Applicable

A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma

ProgenaBiome1 site in 1 countryOctober 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Skin Cancer
Sponsor
ProgenaBiome
Locations
1
Primary Endpoint
Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing
Status
Withdrawn
Last Updated
11 months ago

Overview

Brief Summary

This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.

Detailed Description

The human Skin microbiome is a complex, interconnected web of microbes, living in a symbiotic relationship with their host. There are greater than ten times more bacteria on our bodies than there are human cells, all in a delicate and ever-changing balance to maintain a healthy skin microbiome. When this balance is disrupted, a condition known as dysbiosis, disease can occur. There is still a debate over whether dysbiosis is a cause of disease or a symptom of it. Naturally, since the microbiome has such a profound impact on human health, we want to study and learn as much about the microbiome as possible. By correlating this data with medical records for the patient's skin cancer, connections may begin to be drawn between organisms present in the microbiome of the skin microbiome, and skin cancer. Much like fingerprints, no microbiome is identical therefore the only chance we have at understanding disease is by looking at the skin microbiome and comparing the microorganisms on a patient with skin cancer biopsy and non-skin cancer biopsy.

Registry
clinicaltrials.gov
Start Date
October 2019
End Date
December 2020
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ProgenaBiome
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent
  • 18 years of age or older
  • Diagnosis of skin cancer, both melanoma and non-melanoma
  • Able/willing to have a skin punch biopsy in a non-cancerous location

Exclusion Criteria

  • Unable/unwilling to sign informed consent
  • Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

Outcomes

Primary Outcomes

Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing

Time Frame: 1 year

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the skin microbiome in both cancerous and non-cancerous areas. These data will then be compared to elucidate unique qualities of the microbiome in skin cancer.

Secondary Outcomes

  • Validation of sequencing methods(1 year)

Study Sites (1)

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