Trial Title:
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study
NCT ID:
NCT06493786
Condition:
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
Conditions: Official terms:
Melanoma
Skin Neoplasms
Carcinoma, Basal Cell
Body Odor
Conditions: Keywords:
collection of body odor samples
volatile biomarkers
various skin cancers
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Collection of body odor samples
Description:
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.
Arm group label:
Basocellular carcinoma (BCC)
Arm group label:
Epidermoid carcinoma (EC)
Arm group label:
Healthy volunteers
Arm group label:
Malignant melanoma (MM)
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For patients
1. Adult patient (age ≥ 18 years),
2. 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),
3. Patient with a lesion located on a flat surface measuring at least 3 cm by 2
cm,
4. 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,
5. Patient who has not handled odorous substances (e.g. household products,
paints) in the 24 hours prior to sampling,
6. Patient who has not eaten a meal (or flavored substances such as drinks or
sweets) within 2 hours of sampling,
7. Patient able to read, understand and give documented informed consent,
8. Patient willing and able to comply with protocol requirements for the duration
of the study,
9. Patient affiliated or entitled to a social security scheme,
10. for patients of childbearing potential, negative pregnancy test at inclusion.
- For healthy subjects
1. Adult subject (age ≥ 18 years),
2. Subject who, in the judgement of the dermatological investigator, does not have
a suspicious or pre-cancerous skin lesion suggestive of skin cancer.
3. 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,
4. Subject not to have handled odorous substances (e.g. household products,
paints) in the 24 hours prior to sampling,
5. Subject not having eaten a meal (or flavored substances such as drinks or
sweets) in the 2 hours prior to sampling,
6. Subject able to read, understand and give documented informed consent,
7. Willing and able to comply with protocol requirements for the duration of the
study.
8. Subject affiliated or entitled to a social security plan,
9. For subjects of childbearing potential, negative pregnancy test at inclusion.
Exclusion Criteria:
1. Patient or subject who has expressed opposition to participation in the study,
2. Patient or subject under guardianship, deprived of liberty, under psychiatric care
or hospitalized in a health or social institution,
3. Patient or subject linguistically unable to understand the terms of the study,
4. Pregnant and/or breast-feeding and/or likely to become pregnant,
5. Patient or subject with a known allergy to adhesive dressings,
6. Patient or subject with inflammatory skin disease, infectious skin disease or any
other suspicious or pre-cancerous skin lesion,
7. Patient or subject with a known history of progressive cancer within the last five
(5) years,
8. Patient or subject with an additional condition which, in the opinion of the
investigator, may interfere with the evaluation of the drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
July 25, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Association pour la Recherche Clinique et Immunologique
Agency class:
Other
Collaborator:
Agency:
SenseBioTek Health-Care
Agency class:
Other
Collaborator:
Agency:
ESPCI Paris
Agency class:
Other
Source:
Association pour la Recherche Clinique et Immunologique
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06493786
