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Trial record 6 of 11 for:    progenabiome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04099446
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Information provided by (Responsible Party):

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

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Study Type : Observational
Estimated Enrollment : 25 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing [ Time Frame: 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 [ Time Frame: 1 year ]
    To validate the sequencing methods used to generate microbiome data

Biospecimen Retention:   Samples With DNA
Punch biopsies of skin from both cancerous and non-cancerous areas.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults 18 and older with a diagnosis of skin cancer

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04099446

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Contact: Jordan Daniels, MS 805-339-0549
Contact: Sabine Hazan 805-339-0549

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United States, California
Ventura, California, United States, 93003
Sponsors and Collaborators
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Principal Investigator: Sabine Hazan, MD ProgenaBiome

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Responsible Party: ProgenaBiome Identifier: NCT04099446     History of Changes
Other Study ID Numbers: ProgenaBiome-003
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only aggregated, deidentified data will be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases