Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493786
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples a Pilot Study
Sponsor:
Association pour la Recherche Clinique et Immunologique
Organization:
Association pour la Recherche Clinique et Immunologique
Study Overview
Official Title:
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCENT-SKIN-001
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
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-GCxGCToFMS 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None