Clinical trial NCT04475952: Early Diagnosis of Upper Digestive Tract Disease
Official title: Early Diagnosis of Upper Digestive Tract Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma
Breath Test
Digestive System Disease
Diagnose Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited from secondary care will have been referred by their responsible clinician to undergo either a laryngoscopy (which involves visualisation of the highest part of the oesophagus, larynx and vocal cords, upper gastrointestinal endoscopy (which involves a telescope test to visualise the oesophagus, stomach and duodenum) or a lower gastrointestinal endoscopy (which involves a telescope test to visualise the colon) or surgery. No other investigations will be required.

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.

Primary outcomes:
measure: Non-invasive testing
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
References: