NCT04475952 Early Diagnosis of Upper Digestive Tract Disease
| NCT ID | NCT04475952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2019-09-13 |
| Primary Completion | 2025-09-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2019-09-13 with a primary completion date of 2025-09-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients presenting with this disease are diagnosed late and have poor overall survival rates (\<20%). NICE referral guidelines for diagnostic endoscopy are usually associated with late disease. Exhaled breath testing is a non-invasive and acceptable technology utilising mass spectrometry (MS) which has shown promise at diagnosing cancer at an early stage. Previous research has shown that products formed as a result of metabolism can be measured in breath and saliva (biomarkers). This has the ability to accurately identify patients with upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated that changes in the breakdown of metabolites release volatile organic compounds (VOC) which can be measured with MS. This data is supported by other patient studies. However no previous study has been performed utilising a non-invasive technique with breath and saliva. Thus the aim of this study is to identify VOCs present in patients with this disease. In this multi-centre study the investigators want to overcome the limitations of previous work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple sites. The investigators aim to conduct a study in patients with UDC and those without. The investigators hope that the results of this study will provide evidence for large scale analysis of patients with this disease, demonstrate the feasibility of this technique and move this valuable test forward into mainstream medical practice. The major advantage of this test is that it is easy to undertake and painless for the patient. This study of products in breath, saliva and urine will be useful for detecting UDC to allow treatment at an early stage, improving overall survival.
Eligibility Criteria
Inclusion Criteria: * Any patient who: * is ≥ 18 years old and below 90 years of age, AND: * is undergoing endoscopy as part of their routine clinical care, OR: * is undergoing surgical resection of orodigestive tract disease as part of their routine clinical care, OR: * is undergoing treatment of orodigestive tract disease as part of their routine clinical care Exclusion Criteria: * Any patient who: * Lacks capacity or is unable to provide informed consent. * Any patient below 18 years of age or over 90 years of age.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04475952 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04475952 currently recruiting?
Yes, NCT04475952 is actively recruiting participants. Contact the research team at y.goh@imperial.ac.uk for enrollment information.
Where is the NCT04475952 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04475952 clinical trial?
NCT04475952 is sponsored by Imperial College London. The trial plans to enroll 180 participants.