Skin CancerNCT04099446
A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
An observational study of Skin Cancer and Melanoma (Skin), run by ProgenaBiome at 1 site in United States.
Trial summary
This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Melanoma (Skin), Squamous Cell Carcinoma
- What is being tested?
- Non-interventional
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18 and older with a diagnosis of skin cancer
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma
This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.
Read the 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.
- Being tested
- Non-interventional
- Medical subject headings
- Skin Neoplasms, Melanoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
There is no intervention for this study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Validation of sequencing methods
To validate the sequencing methods used to generate microbiome data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099446
- Sponsor's protocol ID
- PRG-003
- Status last verified
- Apr 2021
- First submitted
- 18 Sep 2019
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated, deidentified data will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma
- ClinicalTrials.gov ID
- NCT04099446
- Acronym / sponsor ID
- PRG-003
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 and older with a diagnosis of skin cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalThere is no intervention for this study | Other | – |
Primary outcome
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.
1 secondary outcome
Validation of sequencing methods
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No. Only aggregated, deidentified data will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Melanoma (Skin), run by ProgenaBiome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.