Early Diagnosis of Upper Digestive Tract Disease

Squamous Cell Carcinoma Clinical Trial

— E-DIGEST  

Official title:

Early Diagnosis of Upper Digestive Tract Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475952
• Other study ID #: IRAS 257483
• Status: Recruiting
• Start date: September 13, 2019
• Est. completion date: September 13, 2024

Study information

• Verified date: October 2023
• Source: Imperial College London
• Contact: Yan Mei Goh, MBChB, MRCS
• Phone: 0207 594 3396
• Email: y.goh[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 13, 2024
• Est. primary completion date: September 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breath Test
• Diagnose Disease
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Squamous Cell Carcinoma

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive testing	Samples such as exhaled breath, urine, saliva, tissue and blood will be obtained from patients. These will be analysed with mass spectrometry to identify the compounds changed in patients with the target disease and those without.	5 years