Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study (SCENT-SKIN-001)

July 2, 2024 updated by: Association pour la Recherche Clinique et Immunologique

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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-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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Malignant melanoma (MM)

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.
Other: Basocellular carcinoma (BCC)

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.
Other: Epidermoid carcinoma (EC)

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.
Other: Healthy volunteers

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of chromatographic profiles of skin VOCs
Time Frame: 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association pour la Recherche Clinique et Immunologique

Collaborators

ESPCI Paris
SenseBioTek Health-Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 25, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00450-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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