MelanomaNCT02393001
Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques
An observational study of Melanoma, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Dermatology patients
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 3 Oct 2017
- 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: Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin
Who may be able to join
- 18 years of age or older
- Seen at the dermatology clinic \& determined to need a skin biopsy of a suspicious lesion
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.
Read the detailed description
Types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. At this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer.
This research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. The swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.
- Conditions
- Melanoma
- Being tested
- Dermatology patients
- Keywords
- skin cancer, suspicious lesion, skin biopsy, noninvasive, screening
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatology patientsOther
Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.
Dermatology patientsOther
Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.
Dermatology patientsOther
This intervention follows the standard of care for patients with a suspicious skin lesion (potential melanoma) the physician plans to biopsy. The alcohol swab used to prep the site will be stored for testing rather than discarded.
Dermatology patientsOther
Cleanse an area of unafflicted (control) skin with an alcohol swab.
| Study group | Role | What they receive |
|---|---|---|
| Dermatology patients | Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin. Receives: Other: Dermatology patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies.
Determine if the melanomas have unique identifying spectra that might be applied to noninvasive melanoma skin cancer screening in lieu of taking a biopsy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMay 2015
- Primary completion30 Sep 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaus Gravenstein, MD, Principal investigator, The Jerome H. Modell, MD, Professor of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393001
- Sponsor's protocol ID
- IRB201400739
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2015
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques
- ClinicalTrials.gov ID
- NCT02393001
- Acronym / sponsor ID
- IRB201400739
- Conditions
- Melanoma
- Keywords
- skin cancer, suspicious lesion, skin biopsy, noninvasive, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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.
The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.
Detailed description
Types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. At this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer.
This research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. The swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermatology patients | – | Other: Dermatology patientsPatients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin
Key inclusion criteria (2 listed)
- 18 years of age or older
- Seen at the dermatology clinic \& determined to need a skin biopsy of a suspicious lesion
Key exclusion criteria (1 listed)
- < 18 years of age
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 |
|---|---|---|
| Dermatology patientsCleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline. | Other | Dermatology patients |
| Dermatology patientsCleanse a suspicious lesion (potential melanoma) with a saline cotton swab. | Other | Dermatology patients |
| Dermatology patientsThis intervention follows the standard of care for patients with a suspicious skin lesion (potential melanoma) the physician plans to biopsy. The alcohol swab used to prep the site will be stored for testing rather than discarded. | Other | Dermatology patients |
| Dermatology patientsCleanse an area of unafflicted (control) skin with an alcohol swab. | Other | Dermatology patients |
Primary outcome
Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies.
Time frame: 1 day
Determine if the melanomas have unique identifying spectra that might be applied to noninvasive melanoma skin cancer screening in lieu of taking a biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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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.
Nikolaus Gravenstein, MD principal investigator
The Jerome H. Modell, MD, Professor of Anesthesiology
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 Melanoma, run by University of Florida 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies. (time frame: 1 day). 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 24 Jul 2019.