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

Sponsor
ProgenaBiome (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04099446
Collaborator
(none)
0
1
14
0

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Non-interventional

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 Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Validation of sequencing methods [1 year]

    To validate the sequencing methods used to generate microbiome data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProgenaBiome Ventura California United States 93003

Sponsors and Collaborators

  • ProgenaBiome

Investigators

  • Principal Investigator: Sabine Hazan, MD, ProgenaBiome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProgenaBiome
ClinicalTrials.gov Identifier:
NCT04099446
Other Study ID Numbers:
  • ProgenaBiome-003
First Posted:
Sep 23, 2019
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021