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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04099446
Enrollment
0
Registered
2019-09-23
Start date
2019-10-31
Completion date
2020-12-31
Last updated
2025-06-05

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

Conditions

Basal Cell Carcinoma, Melanoma (Skin), Microbiome, Skin Cancer, Squamous Cell Carcinoma

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.

Interventions

OTHERNon-interventional

There is no intervention for this study

Sponsors

ProgenaBiome
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing1 yearRelative 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

MeasureTime frameDescription
Validation of sequencing methods1 yearTo validate the sequencing methods used to generate microbiome data

Countries

United States

Outcome results

None listed

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