Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study

Launched by ASSOCIATION POUR LA RECHERCHE CLINIQUE ET IMMUNOLOGIQUE · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether certain smells from the skin can help identify different types of skin cancer, such as malignant melanoma, basal cell carcinoma, and squamous cell carcinoma. Researchers will collect odor samples from patients with these skin cancers and compare them to samples from healthy individuals. The goal is to discover specific odors that are linked to these cancers, which could lead to new ways of diagnosing skin cancer.

To participate in this study, you need to be at least 18 years old and either have a confirmed diagnosis of one of the targeted skin cancers or be a healthy individual with no suspicious skin lesions. Participants will need to avoid using any perfumes, lotions, or strong-smelling products 24 hours before the sample collection, and they should not eat or drink anything for a couple of hours prior. Those who join the study can expect a straightforward process, and their contributions will help advance research into skin cancer detection.

Gender

ALL

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.