Status:
NOT_YET_RECRUITING
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study
Lead Sponsor:
Association pour la Recherche Clinique et Immunologique
Collaborating Sponsors:
SenseBioTek Health-Care
ESPCI Paris
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
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, f...
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 le...
Eligibility Criteria
Inclusion
- 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,
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06493786
Start Date
July 25 2024
End Date
July 31 2025
Last Update
July 10 2024
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