Clinical trial NCT04206995: Cancer Sensing: Evaluation of Odour Sampling Techniques
Official title: Cancer Sensing: Evaluation of Odour Sampling Techniques to Support the Non-invasive Early Detection of Skin Cancer - Proof of Concept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Poole Hospital NHS Foundation Trust
name: Dorset County Hospital NHS Foundation Trust
First posted: 2019-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Skin odour samples are obtained from patients who are diagnosed with cancer and during their visit to Poole or Dorset County Hospitals. Skin odour samples of healthy people will also be obtained from staff and students at Bournemouth University.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the suitability of the adsorptive patch for collecting VOCs for analysis for early identification of skin cancer.
timeFrame: 30 minutes
measure: Evaluate the suitability of the Solid Phase Microextraction (SPME) for analysis for early identification of skin cancer.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
state: Dorset
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust
state: Dorset
Study officials:
affiliation: Bournemouth University
name: Richard Paul, PhD
role: STUDY_DIRECTOR
References: