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

NCT04099446 | Withdrawn DMC

• 1 other identifier: PRG-003
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validation of sequencing methods

  1 year

Interventions

Non-interventional OTHER

There is no intervention for this study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults 18 and older with a diagnosis of skin cancer

You may qualify if:

• Signed informed consent
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Punch biopsies of skin from both cancerous and non-cancerous areas.

MeSH Terms

Conditions

Skin Neoplasms; Melanoma; Carcinoma, Squamous Cell; Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Neoplasms, Basal Cell

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 5, 2025

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)