An interventional study of Collection of body odor samples in 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, sponsored by Association pour la Recherche Clinique et Immunologique. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Association pour la Recherche Clinique et Immunologique · Not applicable, Interventional, and Other
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 120 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Association pour la Recherche Clinique et Immunologique is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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For patients
For healthy subjects
Exclusion Criteria:
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
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
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
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
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.
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.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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