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

NCT06493786 | Not Yet Recruiting

• 1 other identifier: 2024-A00450-47
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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, 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (4)

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.

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.

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.

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.

Other: Collection of body odor samples

Interventions

Collection of body odor samples OTHER

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.

Basocellular carcinoma (BCC); Epidermoid carcinoma (EC); Healthy volunteers; Malignant melanoma (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association pour la Recherche Clinique et Immunologique: lead
• SenseBioTek Health-Care: collaborator
• ESPCI Paris: collaborator

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Central Study Contacts

Sophie Gilibert

CONTACT

+33 6 65 37 50 08; sophie.gilibert@lyonrechercheclinique.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 25, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share