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

Withdrawn

• Conditions: Squamous Cell Carcinoma; Microbiome; Melanoma (Skin); Skin Cancer; Basal Cell Carcinoma

• Registration Number: NCT04099446
• Lead Sponsor: ProgenaBiome

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.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2019-10
• Primary Completion: 2020-10
• Study Completion: 2020-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing	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 Outcome Measures

Name	Time	Method
Validation of sequencing methods	1 year	To validate the sequencing methods used to generate microbiome data

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States