Cancer Sensing: Evaluation of Odour Sampling Techniques

Sponsor
Bournemouth University (Other)
Overall Status
Completed
CT.gov ID
NCT04206995
Collaborator
Poole Hospital NHS Foundation Trust (Other), Dorset County Hospital NHS Foundation Trust (Other)
20
2
2.6
10
3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Solid Phase Microextraction (SPME)
  • Other: Absorptive patch

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Cancer Sensing: Evaluation of Odour Sampling Techniques to Support the Non-invasive Early Detection of Skin Cancer - Proof of Concept
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Nov 18, 2021
Actual Study Completion Date :
Nov 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Evaluation of odour capturing techniques

To evaluate two odour capturing techniques to compare VOC profiles of cancerous and healthy skin cancer.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the suitability of the adsorptive patch for collecting VOCs for analysis for early identification of skin cancer. [30 minutes]

    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.

  2. Evaluate the suitability of the Solid Phase Microextraction (SPME) for analysis for early identification of skin cancer. [30 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dorset County Hospital NHS Foundation Trust Dorchester Dorset United Kingdom DT1 2JY
2 University Hospitals Dorset NHS Foundation Trust Poole Dorset United Kingdom BH15 2JB

Sponsors and Collaborators

  • Bournemouth University
  • Poole Hospital NHS Foundation Trust
  • Dorset County Hospital NHS Foundation Trust

Investigators

  • Study Director: Richard Paul, PhD, Bournemouth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bournemouth University
ClinicalTrials.gov Identifier:
NCT04206995
Other Study ID Numbers:
  • Skin cancer sensing by VOCs
First Posted:
Dec 20, 2019
Last Update Posted:
Jan 5, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022