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An Exploratory Study Investigating the Potential of a Rectal Mucus Sample for Development of Biomarker Assays in Subjects With Gastrointestinal Diseases (ORI-EGI-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04659590
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : April 1, 2021
Information provided by (Responsible Party):
Origin Sciences

Brief Summary:

The identification of patients with colorectal cancer is challenging as they present with a variable symptom profile and require invasive tests (colonoscopy) for diagnosis (through histological analysis of biopsies) and complimented by cross-sectional radiology, prior to commencement of treatment. The biopsy forms the basis of the diagnosis and management planning for a patient with colorectal cancer through the multidisciplinary team.

The biggest challenge currently faced in the management of colorectal cancer is the accurate identification of patients who present with various symptoms none of which are specific for bowel cancer. Currently the NICE referral guidelines are used to determine the appropriateness of referral pathway, i.e. Fast-Track/Two-Week Wait referral. A recent review of over 10000 referrals revealed a colorectal cancer diagnosis in 4.1% of referrals. Previous literature reports rates as high as 8%, but in series of cases with only 72-89% adherence to the referral guidance leading to at best 40% of all colorectal cases being diagnosed through this route. The remainder of colorectal cancers being diagnosed through the bowel cancer screening programme (NBCSP), non-two-week wait referrals and other processes such as emergency admissions. Inherently the Two-Week Wait pathway refers a large volume of "symptomatic patients" and it has become a "cancer exclusion pathway." Once cancer has been excluded, patients are often discharged back to General Practice, yet the patients often still have symptoms. The current Covid-19 pandemic has had a significant impact on the already pressed Two-Week pathway impacting on the reduction of endoscopic and radiological appointments available leading to delays in treatment. Each test performed in the diagnostic pathway has a significant financial, personal, and institutional resource profile.

It is our aim to develop a novel diagnostic device based upon the identification of genetic mutations and genomic alterations from material trapped in the rectal mucous layer allowing focused endoscopic assessment, confirmation/exclusion of cancer diagnosis from cross-sectional imaging in those unfit for endoscopic examination and identification of high-risk lesions (dysplasia). This would allow a greater triage, and focus colonoscopic services onto therapeutic procedures, improving overall care.

Condition or disease
Bowel Cancer Bowel Disease Genomic Epigenetic Disorder

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory Study Investigating the Potential of a Rectal Mucus Sample for Development of Biomarker Assays in Subjects With Gastrointestinal Diseases
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Stability of buffer transfer medium [ Time Frame: through study, an average of 1 year ]
    Sample loss rate

Secondary Outcome Measures :
  1. Comparison to qFiT test [ Time Frame: through study, an average of 1 year ]
    Comparison to pathology identified

  2. Comparison between tumour surface imprint and rectal mucous imprint [ Time Frame: through study, an average of 1 year ]
    Comparison between tumour imprint surface and rectal mucous imprint

Biospecimen Retention:   Samples With DNA
Banked DNA retrieved from specimen taken from bowel lumen

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with known or suspected gastrointestinal disease(s).

Inclusion Criteria:

General inclusion criteria:

  • aged 18 years or over
  • be able to give voluntary, written informed consent to participate in the study

Exclusion Criteria:

  • Subjects with confirmed collagenous colitis or symptoms that would make proctoscopic examination inappropriate, including acute anal fissure, symptomatic thrombosed haemorrhoids or obstructing anorectal tumours as determined by rectal examination
  • Subjects with a previous history of cancer or who have previously received radiotherapy, chemotherapy or immunotherapy

The following populations will be included:

  • Subjects with confirmed colorectal cancer
  • Subjects with suspected colorectal cancer
  • Subjects with known or suspected inflammatory bowel disease
  • Known controls

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04659590

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Contact: Ian Daniels, FRCS +447920517187
Contact: Jenny Searle 01223750490

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United Kingdom
Royal Cornwall Hospital Recruiting
Truro, Cornwall, United Kingdom, TR1 3LQ
Contact: Nicholas Battersby         
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Christopher Cunningham         
Royal Shrewsbury & Telford Hospitals NHS Trust Recruiting
Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
Contact: Jonathon Lacy-Colson         
Royal Devon & Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom, EX2 4UG
Contact: Ian Daniels    +447920517187   
Sponsors and Collaborators
Origin Sciences
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Principal Investigator: Jon Lacy-Colson, FRCS Royal Shrewsbury Hospital
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Responsible Party: Origin Sciences Identifier: NCT04659590    
Other Study ID Numbers: 263745
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases