NCT04206995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

December 13, 2019

Last Update Submit

January 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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)Other: Absorptive patch

Interventions

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.

Evaluation of odour capturing techniques

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.

Evaluation of odour capturing techniques

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients diagnosed with skin cancer, able to speak and understand written English,
  • years or older and
  • Capable of giving informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Poole, Dorset, BH15 2JB, United Kingdom

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Solid Phase Microextraction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Solid Phase ExtractionChemical FractionationChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Richard Paul, PhD

    Bournemouth University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 20, 2019

Study Start

September 1, 2021

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations