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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04099446
• Other study ID #: ProgenaBiome-003
• Status: Withdrawn
• Start date: October 2019
• Est. completion date: December 2020

Study information

• Verified date: April 2021
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Non-interventional
There is no intervention for this study

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing	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.	1 year
Secondary	Validation of sequencing methods	To validate the sequencing methods used to generate microbiome data	1 year