Condition category
Cancer
Date applied
07/11/2016
Date assigned
15/11/2016
Last edited
15/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Colorectal cancer (CRC), also known as bowel cancer, is the third most common cancer. It is a global healthcare problem, causing almost 700,000 deaths worldwide every year. This disease usually affects people over the age of 50 and does not produce symptoms at its early stages. Very often CRC is detected too late to be successfully treated. Early detection of this cancer, especially through population screening, saves lives, but the existing tests used for this purpose are not sensitive enough or too expensive. DiagNodus Ltd has recently developed a new technique for collecting samples of colorectal mucus which can be used to measure the levels of chemicals called biomarkers and detect inflammatory bowel disease (IBD). As it is well known that CRC also produces dramatic changes in colorectal mucus, it is highly likely that CRC biomarkers can be found in this material as well. The aim of this study is to examine if the new approach devised by DiagNodus Ltd is suitable for detecting CRC.

Who can participate?
Patients aged over 45 with confirmed colorectal cancer, and tumour-free patients for comparison

What does the study involve?
Participants have their diagnoses confirmed by colonoscopy, a test where the doctor looks at the inner lining of the colon using a thin, flexible tube. Participants are then provided with a kit for sample collection and are instructed to collect two samples of colorectal mucus 3-5 days after colonoscopy (CRC patients usually have surgery at least two weeks after colonoscopy). Sample collection is performed by the participants at home. Once samples are collected, they are sent to the laboratory of DiagNodus Ltd, where all planned laboratory tests are carried out. The results of the tests are matched to diagnostic information (colonoscopy) at the end of the study.

What are the possible benefits and risks of participating?
Although patients are unlikely to benefit from participating, the results of the study are likely to provide significant benefits for patients and medical professionals in terms of developing a new approach to CRC early detection and screening. The eventual goal is to provide a simple, highly sensitive and affordable test for CRC screening. Providing samples does not interfere with routine treatment. Sample collection is safe and very well accepted by patients. For these reasons no potential risks of participating in the study can be identified.

Where is the study run from?
1. DiagNodus Ltd (UK)
2. St George's Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2017 to December 2019

Who is funding the study?
DiagNodus Ltd (UK)

Who is the main contact?
Dr Alexandre Loktionov

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandre Loktionov

ORCID ID

http://orcid.org/0000-0001-7836-3838

Contact details

DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Screen2C-012017-Pilot 3

Study information

Scientific title

Colorectal cancer detection by quantifying biomarkers in non-invasively collected colorectal mucus: an observational case-control study

Acronym

Study hypothesis

The main hypothesis is that colorectal mucus excreted during bowel opening constitutes a highly informative material that can be successfully analysed for non-invasively detecting biomarkers of colorectal cancer presence. Performance of a range of candidate biomarkers is going to be tested in order to select the best diagnostic marker(s).

Ethics approval

Not provided at time of registration

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Colorectal cancer

Intervention

At the initial (pilot) stage of this observational case-control study it is planned to recruit at least 50 patients with colorectal cancer (between diagnostic colonoscopy and surgery) and 50 neoplasia-free (endoscopically confirmed) patients. All recruited patients are asked to collect samples of colorectal mucus. The collected samples are used for quantitative biomarker determination (ELISA for protein biomarkers; possibly PCR-based techniques for DNA and RNA) and cytological examination. All analytical procedures are blinded with regard to patient identity and diagnosis. At the end of the study the results of sample analysis are compared with the corresponding diagnostic information (reference standard: colonoscopy) (unblinding). Conclusions on individual biomarker performance are made, and larger scale further study is planned if the pilot phase is successful. The pilot phase is planned to be completed by 31/12/2017, and the decision to extend the study beyond this date depends on its outcome.

Intervention type

Other

Phase

Drug names

Primary outcome measures

All results will be obtained at a single time point.

Protein biomarkers:
1. Calprotectin measured using ELISA
2. EDN measured using ELISA
3. MUC2 measured using ELISA
4. MMP9 measured using ELISA
5. VEGF measured using ELISA
6. Soluble Cytokeratin 18 measured using ELISA
7. M2-PK measured using ELISA
8. Haemoglobin measured using ELISA
9. Measurement of additional protein biomarkers may be introduced at later stages of the project

Nucleic acid markers:
1. Total DNA measured by spectrophotometry
2. Total DNA measured by real time PCR (beta-globin gene fragment amplification)
3. Measurement of additional DNA & RNA markers may be introduced at later stages of the project

Cytology and immunocytochemistry:
1. Qualitative cytological examination of collected samples using microscopy
2. Immunocytochemical visualisation of protein biomarkers and qualitative assessment of their distribution using microscopy

Secondary outcome measures

Performance of each of the biomarkers/assays listed above as a diagnostic test comparing CRC presence versus CRC absence, measured by ROC (receiver operating characteristic) curve analysis (area under the curve, sensitivity, specificity) and calculation of test negative and positive predictive values as well as positive and negative likelihood ratios

Overall trial start date

01/01/2017

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Colorectal cancer (case) group: the presence of endoscopically confirmed colorectal cancer
2. Control group: absence of neoplasia confirmed by endoscopy
3. Aged over 45

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100-150 (pilot phase)

Participant exclusion criteria

1. Age below 45
2. The presence of active gastrointestinal diseases or major gastrointestinal surgery in the past
3. Ongoing treatment with hormonal, immunosuppresive or cytostatic drugs

Recruitment start date

15/01/2017

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

DiagNodus Ltd
Bldg 280 Babraham Research Campus
Cambridge
CB22 3AT
United Kingdom

Trial participating centre

St George's Hospital
Blackshaw Rd
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

DiagNodus Ltd

Sponsor details

Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
United Kingdom
+44 (0)1223 497181
info@diagnodus.com

Sponsor type

Industry

Website

http://www.diagnodus.com

Funders

Funder type

Industry

Funder name

DiagNodus Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

It is planned to publish the future results of this study in peer-reviewed biomedical journals. Study outcome will also be presented at international scientific conferences.

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Dr Andrew Poullis (apoullis@sgul.ac.uk; Andrew.Poullis@stgeorges.nhs.uk) on reasonable request.

Intention to publish date

31/12/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes