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Exploratory Study of Rectal Mucus for Diagnosing Disease

ABSTRACT: 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.

DISEASE(S): Bowel Cancer,Intestinal Diseases,Bowel Disease,Epigenetic Disorder,Genomic

PROVIDER: 2360066 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: A two-arm parallel randomised control trial (RCT) will be used to test a theory based implementation approach (Theoretical Domains Framework Implementation) against a non-theory based implementation approach to improving identification of Lynch syndrome amongst colorectal cancer patients. At each hospital, a locally employed healthcare professional will be appointed as a paid ‘Implementation Lead’ (IL) at one day per week over a 24-month period to coordinate the implementation approach and to oversee data collection. They will have a professional understanding of the LS patient pathway, and the ability to motivate other LS stakeholders to engage with implementation processes. Each Implementation Lead will participate in a 1-day training seminar by a health psychologist from the CCNSW research team in one of two approaches (theory or non-theory). CIA Taylor developed the following training toolkit and 1-day course: http://www.improvementacademy.org/tools-and-resources/abc-for-patient-safety-toolkit.html. These training materials have been refined for this study and modified according to trial arm. Those in the theory-based trial arm will be trained in the Theoretical Domains Framework Implementation (TDFI) approach. Following training, the Implementation Lead will work through the following steps at their hospital over a 24-month period: 1. Extract baseline audit data: Clinical data from surgical, pathology and FCC databases will be extracted to determine proportion of pts appropriately referred 2. Form Implementation Team: will form a team of 8-10 multidisciplinary staff involved in the LS referral and diagnosis pathway (e.g. genetic counsellors, CRC surgeons, oncologists, pathologists, nurses, admin etc) 3. Map referral process and identify targets for change: 2 x meetings to map current processes and (using audit data) identify areas for change 4. Identify barriers to change: Staff to complete 5 min questionnaire about perceived barriers & foc Primary outcome(s): The primary outcome will be the proportion of patients with risk-appropriate completion of the LS referral pathway. Clinical and referral data will be extracted from a number of sources (e.g. hospital, pathology and genetics databases) to assess whether patients at high-risk of Lynch syndrome (e.g. those mismatch repair deficient or high level microsatellite instability colorectal cancer tumours) were referred to a familial cancer clinic for consideration of germline Lynch syndrome testing.[Completion of the LS referral pathway within 2 months of CRC resection.] Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:Infection in diabetic foot ulcers (DFU) are one of the major complications associated with diabetic patients. Staphylococcus aureus is the most common offending pathogen in patients with infected DFU. Previous studies have suggested application of species-specific antibodies against S. aureus for diagnosis and monitoring treatment response. Early and accurate identification of the main pathogen is critical for management of DFU infection. Understanding the host immune response against species-specific infection may facilitate diagnosis and suggest potential intervention options to promote healing infected DFUs. We sought to investigate evolving host transcriptome associated with surgical treatment of S. aureus infected DFU. This study compared the transcriptome profile of twenty-one patients with S. aureus infected DFU who underwent initial foot salvage therapy with irrigation and debridement followed by intravenous antibiotics therapy. Blood samples were collected at the recruitment (0-weeks) and 8-week after therapy to isolate peripheral blood mononuclear cells (PBMC). We analyzed the PBMCs expression of transcriptomes at two different time points (0 vs 8-week). Subjects were further divided into two groups at 8-week: healed (n=17, 80.95%) versus non-healed (n=4,19.05%) based on the wound healing status. DESeq2 differential gene analysis was performed. An increased expression of IGHG1, IGHG2, IGHG3 and IGLV3-21, IGLV6-57 were noted during active infection at 0-week compared to 8-week. Lysine and arginine-rich histones (HIST1H2AJ, HIST1H2AL, HIST1H2BM, HIST1H3B and HIST1H3G) were upregulated at the initial phase of active infection at 0-week. CD177 and RRM2 were also upregulated at the initial phase of active infection (0-week) compared to 8-week follow-up. Genes of heat shock protein members (HSPA1A, HSPE1, and HSP90B1) were high in not-healed compared to healed patients 8-week after therapy. The outcome of our study suggests that identification of genes evolution based on a transcriptomic profiling could be a useful tool for diagnosing infection, assessing severity and assess host-immune response to therapies.

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Exploratory Study of Rectal Mucus for Diagnosing Disease

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