Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell CarcinomaSCENT-SKIN-001NCT06493786
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study
A study testing Collection of body odor samples in people with Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma and Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions, run by Association pour la Recherche Clinique et Immunologique.
Trial summary
The aim of this research is to determine which volatile organic compounds (odors) are associated with different skin cancers. To this end, odor samples will be taken from various parts of the body, from patients with skin cancers and from "healthy" subjects who have no skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma, Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions
- What is being tested?
- Collection of body odor samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients
- Adult patient (age ≥ 18 years),
- Patient with a diagnosis of skin cancer of the malignant melanoma, basal cell carcinoma or squamous cell carcinoma type, established by in vivo imaging of the confocal microscopy or LC-OCT type, more than 24 hours old (definitive confirmation being made by anatomopathological examination of the postoperative excision specimen),
- Patient with a lesion located on a flat surface measuring at least 3 cm by 2 cm,
- Patient who has not applied any cosmetic products, such as deodorant, perfume, perfumed cream or soap, or hair care products, in the 24 hours prior to sampling,
- Patient who has not handled odorous substances (e.g. household products, paints) in the 24 hours prior to sampling,
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- Patient who has not eaten a meal (or flavored substances such as drinks or sweets) within 2 hours of sampling,
- Patient able to read, understand and give documented informed consent,
- Patient willing and able to comply with protocol requirements for the duration of the study,
- Patient affiliated or entitled to a social security scheme,
- for patients of childbearing potential, negative pregnancy test at inclusion.
- For healthy subjects
- Adult subject (age ≥ 18 years),
- Subject who, in the judgement of the dermatological investigator, does not have a suspicious or pre-cancerous skin lesion suggestive of skin cancer.
- Subject who has not applied any cosmetic products, such as deodorant, perfume, perfumed cream or soap, or hair care products, in the 24 hours prior to sampling,
- Subject not to have handled odorous substances (e.g. household products, paints) in the 24 hours prior to sampling,
- Subject not having eaten a meal (or flavored substances such as drinks or sweets) in the 2 hours prior to sampling,
- Subject able to read, understand and give documented informed consent,
- Willing and able to comply with protocol requirements for the duration of the study.
- Subject affiliated or entitled to a social security plan,
- For subjects of childbearing potential, negative pregnancy test at inclusion.
Who cannot join
- Patient or subject who has expressed opposition to participation in the study,
- Patient or subject under guardianship, deprived of liberty, under psychiatric care or hospitalized in a health or social institution,
- Patient or subject linguistically unable to understand the terms of the study,
- Pregnant and/or breast-feeding and/or likely to become pregnant,
- Patient or subject with a known allergy to adhesive dressings,
- Patient or subject with inflammatory skin disease, infectious skin disease or any other suspicious or pre-cancerous skin lesion,
- Patient or subject with a known history of progressive cancer within the last five (5) years,
- Patient or subject with an additional condition which, in the opinion of the investigator, may interfere with the evaluation of the drug.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this research is to determine which volatile organic compounds (odors) are associated with different skin cancers.
To this end, odor samples will be taken from various parts of the body, from patients with skin cancers and from "healthy" subjects who have no skin cancer.
The various samples collected will be analyzed in the laboratory, and compared with each other, to determine whether there is a specific "smell" for the main types of skin cancer.
Read the detailed description
The SCENT-SKIN-001 exploratory study aims to identify olfactory biomarkers associated with skin cancers. Body odor samples will be collected from patients with skin cancers at the level of the skin lesion, the area contralateral to the skin lesion, the axillary fossa, the neck, the forearm and the inner thigh, and from healthy subjects at the level of the axillary fossa, the neck, the forearm and the inner thigh. Samples will be analyzed by thermodesorption followed by fully two-dimensional gas chromatography coupled to time-of-flight mass spectrometry (TD-GCxGC/ToFMS). This sample characterization method can separate a much higher number of compounds than the simple GC-MS technique. It has been developed in collaboration with the team at the Laboratoire de Sciences Analytiques, Bioanalytiques et Miniaturisation (LSABM), École Supérieure de Physique et de Chimie Industrielle de la Ville de Paris (ESPCI Paris), and is the subject of a doctoral thesis in analytical chemistry. As part of this analytical method, we have developed a skin VOC sampling device. This is designed to avoid any form of contamination by environmental factors that could influence sample quality.
The study will be carried out on patients newly diagnosed with malignant melanoma, basal cell carcinoma or squamous cell carcinoma, and on "healthy" subjects with no skin cancer.
60 skin cancer patients (20 with Malignant Melanoma, 20 with Basal Cell Carcinoma and 20 with Epidermoid Carcinoma) and 20 to 60 healthy subjects will be included in the study. Thus, the study will involve 80 to 120 people.
The study will be carried out in French hospitals, as well as in a center authorized by the Agence Régionale de Santé (ARS) to conduct clinical trials on healthy subjects.
- Conditions
- Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma, Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions
- Being tested
- Collection of body odor samples
- Keywords
- collection of body odor samples, volatile biomarkers, various skin cancers
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of body odor samplesOther
Skin odor is collected using polymer sticks, placed in contact with the skin for approximately 1 hour.
In this study, odor collection will be carried out on the thigh, forearm, armpit, neck and, if applicable, on the cancerous lesion.
| Study group | Role | What they receive |
|---|---|---|
| Malignant melanoma (MM) | Other | For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:
healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.
* For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. Receives: Other: Collection of body odor samples |
| Basocellular carcinoma (BCC) | Other | For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:
healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.
* For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. Receives: Other: Collection of body odor samples |
| Epidermoid carcinoma (EC) | Other | For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:
healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.
* For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. Receives: Other: Collection of body odor samples |
| Healthy volunteers | Other | For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:
healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.
* For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. Receives: Other: Collection of body odor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of chromatographic profiles of skin VOCs
For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:
healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.
- For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche Clinique et Immunologique
- Sponsor type
- University, hospital or other
- Collaborators
- SenseBioTek Health-Care, ESPCI Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493786
- Sponsor's protocol ID
- 2024-A00450-47
- Acronym
- SCENT-SKIN-001
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study
- ClinicalTrials.gov ID
- NCT06493786
- Acronym / sponsor ID
- SCENT-SKIN-001 / 2024-A00450-47
- Conditions
- Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma, Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions
- Keywords
- collection of body odor samples, volatile biomarkers, various skin cancers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Association pour la Recherche Clinique et ImmunologiqueUniversity, hospital or other
- Collaborators
- SenseBioTek Health-Care, ESPCI Paris
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 Jul 2024 (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.
The aim of this research is to determine which volatile organic compounds (odors) are associated with different skin cancers.
To this end, odor samples will be taken from various parts of the body, from patients with skin cancers and from "healthy" subjects who have no skin cancer.
The various samples collected will be analyzed in the laboratory, and compared with each other, to determine whether there is a specific "smell" for the main types of skin cancer.
Detailed description
The SCENT-SKIN-001 exploratory study aims to identify olfactory biomarkers associated with skin cancers. Body odor samples will be collected from patients with skin cancers at the level of the skin lesion, the area contralateral to the skin lesion, the axillary fossa, the neck, the forearm and the inner thigh, and from healthy subjects at the level of the axillary fossa, the neck, the forearm and the inner thigh. Samples will be analyzed by thermodesorption followed by fully two-dimensional gas chromatography coupled to time-of-flight mass spectrometry (TD-GCxGC/ToFMS). This sample characterization method can separate a much higher number of compounds than the simple GC-MS technique. It has been developed in collaboration with the team at the Laboratoire de Sciences Analytiques, Bioanalytiques et Miniaturisation (LSABM), École Supérieure de Physique et de Chimie Industrielle de la Ville de Paris (ESPCI Paris), and is the subject of a doctoral thesis in analytical chemistry. As part of this analytical method, we have developed a skin VOC sampling device. This is designed to avoid any form of contamination by environmental factors that could influence sample quality.
The study will be carried out on patients newly diagnosed with malignant melanoma, basal cell carcinoma or squamous cell carcinoma, and on "healthy" subjects with no skin cancer.
60 skin cancer patients (20 with Malignant Melanoma, 20 with Basal Cell Carcinoma and 20 with Epidermoid Carcinoma) and 20 to 60 healthy subjects will be included in the study. Thus, the study will involve 80 to 120 people.
The study will be carried out in French hospitals, as well as in a center authorized by the Agence Régionale de Santé (ARS) to conduct clinical trials on healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Malignant melanoma (MM) | Other | Other: Collection of body odor samplesFor each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows: healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall. * For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. |
| Basocellular carcinoma (BCC) | Other | Other: Collection of body odor samplesFor each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows: healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall. * For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. |
| Epidermoid carcinoma (EC) | Other | Other: Collection of body odor samplesFor each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows: healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall. * For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. |
| Healthy volunteers | Other | Other: Collection of body odor samplesFor each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows: healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall. * For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For patients
- For healthy subjects
Key exclusion criteria (8 listed)
- Patient or subject who has expressed opposition to participation in the study,
- Patient or subject under guardianship, deprived of liberty, under psychiatric care or hospitalized in a health or social institution,
- Patient or subject linguistically unable to understand the terms of the study,
- Pregnant and/or breast-feeding and/or likely to become pregnant,
- Patient or subject with a known allergy to adhesive dressings,
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 |
|---|---|---|
| Collection of body odor samplesSkin odor is collected using polymer sticks, placed in contact with the skin for approximately 1 hour. In this study, odor collection will be carried out on the thigh, forearm, armpit, neck and, if applicable, on the cancerous lesion. | Other | Basocellular carcinoma (BCC), Epidermoid carcinoma (EC), Healthy volunteers, Malignant melanoma (MM) |
Primary outcome
Comparison of chromatographic profiles of skin VOCs
Time frame: 12 months
For each group of patients (MM, CBC*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows: healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall. * For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of body odor samples in people with Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma and Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions, run by Association pour la Recherche Clinique et Immunologique.
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 21 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Gilibert (+33 6 65 37 50 08, sophie.gilibert@lyonrechercheclinique.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of chromatographic profiles of skin VOCs (time frame: 12 months). 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 10 Jul 2024.