CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,855 enrolled
Drug / intervention
Breath sampleother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03699163
NCT03699163N/ACompleted

Non-invasive Testing for the Diagnosis and Assessment of Colorectal Disease

Imperial College London·observational·Posted Oct 9, 2018·Updated Nov 21, 2024

In Brief

An observational study evaluating Breath sample for Colorectal Cancer and 2 related conditions. Completed, enrolled 1,855 participants across 8 sites.

Detailed Summary

This study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps. Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal cancer (adenocarcinoma) will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between colorectal cancer, benign colorectal disease (e.g. polyps) and healthy controls.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartJun 3, 2017
Primary CompletionJul 1, 2020
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.7 years ago

Interventions

Breath sampleother

Patients will be asked to give a sample of their breath, using the ReCIVA breath testing device. This involves performing tidal breathing whilst wearing a face mask for approximately 5 minutes. Breath (500mls at a flow rate of 200mls/min) is passed over thermal desorption tubes which absorb compounds of interest.