Cancer Sensing: Evaluation of Odour Sampling Techniques

Skin Cancer Clinical Trial

Official title:

Cancer Sensing: Evaluation of Odour Sampling Techniques to Support the Non-invasive Early Detection of Skin Cancer - Proof of Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206995
• Other study ID #: Skin cancer sensing by VOCs
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: January 2022
• Source: Bournemouth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the suitability of two odour capturing techniques for early detection of skin cancer.

Description:

The study will investigate the suitability of two odour capturing techniques for early detection of skin cancer. The techniques to capture VOCs are: a) solid phase microextraction (SPME) and b) collection of VOCs via an adsorptive patch, worn on the skin. The objective is to evaluate the suitability of two techniques for collecting VOCs.

Odour samples from cancerous and healthy skin will be captured using the two non-invasive techniques. The techniques will initially be tested in a laboratory environment. They will then be applied in parallel to patients and healthy people. VOC compounds of odour samples will be analysed for their profiles in respect of cancerous and healthy skins. The VOCs profiles will be recorded in a VOC bank for future analysis.

Following the initial tests, patients (n=20) with skin cancer will be recruited from Poole and Dorset County Hospitals. Arrangement will be made to obtain odour samples by positioning patches on the cancerous skin sites (for approximately 30 minutes) of patients and recover them. To obtain samples from healthy people (n=10), staff and students within the university are invited to participate in this research by providing odour samples from their skins using the same type of patches.

In parallel, VOCs from skin cancer patients will also be collected from patients with the SPME fibres described earlier. The SPME device is roughly equivalent in size and shape to a ballpoint pen, from the tip of which an adsorbent fibre can be extended. The SPME device is held statically with a flexible clamp (a weighted clamp which rests on a bench / desk near the patient), and is positioned so that the tip of the fibre rests close to, but not touching, the affected skin area. The fibre needs to be held in place to sample the air above the affected skin for a pre-determined period of time, likely to be 15 - 30 minutes. Specifics such as the sampling time and related factors will be evaluated during the initial laboratory testing. Following the defined time period of sampling, the fibre is retracted into the body of the SPME device (to protect it), and the device is returned to the laboratory for analysis. The high temperatures involved in GCMS analysis cause VOCs captured by the SPME device to be released (desorbed) and they are subsequently swept through the GCMS system for analysis.

The VOC samples from both the techniques will be transported to Bournemouth university for analysis.

The outcome will be the identification of the most suitable VOC collection technique (SPME vs patch) by comparing the VOC profiles of cancerous and healthy skin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with skin cancer, able to speak and understand written English,

• 18 years or older and

• Capable of giving informed consent.

Exclusion Criteria:

• Patients too weak to speak or give written informed consent;

• Non-English speaking without an interpreter;

• Patients lacking mental capacity to consent, or

• Below the age of 18.

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Other:
• Solid Phase Microextraction (SPME)
A SPME fibre is held directly above skin cancer, or healthy skin for a period of less than 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.
• Absorptive patch
An adsorptive patch, covering skin cancer and healthy skin sites will be applied for a period of maximum 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.

Locations

Country	Name	City	State
United Kingdom	Dorset County Hospital NHS Foundation Trust	Dorchester	Dorset
United Kingdom	University Hospitals Dorset NHS Foundation Trust	Poole	Dorset

Sponsors (3)

Lead Sponsor	Collaborator
Bournemouth University	Dorset County Hospital NHS Foundation Trust, Poole Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the suitability of the adsorptive patch for collecting VOCs for analysis for early identification of skin cancer.	An adsorptive patch, covering skin cancer and healthy skin sites will be applied for a period of maximum 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.VOCs for analysis for early identification of skin cancer.	30 minutes
Primary	Evaluate the suitability of the Solid Phase Microextraction (SPME) for analysis for early identification of skin cancer.	A SPME fibre is held directly above skin cancer, or healthy skin for a period of less than 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.	30 minutes