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

NCT ID: NCT04099446

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Hazan, MD

Role: PRINCIPAL_INVESTIGATOR

ProgenaBiome

Locations

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ProgenaBiome

Ventura, California, United States

Site Status

Countries

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United States

Other Identifiers

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PRG-003

Identifier Type: -

Identifier Source: org_study_id

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