ENDCaP-C

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Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis (ENDCaP-C): A Multicentre test accuracy study

Over 30,000 patients in the UK are affected by chronic ulcerative colitis (UC) and, as a consequence are at increased risk of colorectal cancer. The risk of cancer rises with duration of disease, reaching 18% after 30 years and results in over 1,000 colectomies being performed each year in the UK for colorectal cancer or cancer prevention. Despite intensive colonoscopic surveillance, as many as 50% of cases progress to invasive cancer before neoplasia is detected. This can prevent safe restoration of bowel continuity, require adjuvant chemotherapy and result in incurable disease and death (in >40% of patients with colitis associated large bowel cancer).

Rationale

There is a pressing need to enhance the effectiveness of surveillance and early selection for prophylactic resection. This was highlighted in the recent NICE guidelines (NICE 2011), which recommend the identification of epigenetic and genetic biomarkers to aid more accurate patient identification. An ideal test would complement colonoscopy and biopsy by providing enhanced detection of pre-cancerous lesions (dysplasia) thereby delivering better patient selection for prophylactic resection.

Objectives

Primary objective

  • To prospectively evaluate the ability of the methylation assay to detect pre-cancerous lesions (dysplasia) missed by histology within a surveillance programme for colitis associated neoplasia (CAN).

Secondary objectives:

  • To estimate the incremental accuracy of methylation testing over histology within a CAN surveillance programme and gain experience of its applicability in the clinical setting.
  • To evaluate the feasibility of testing for hypermethylation of secreted Wnt antagonists in serum and faecal samples, and if feasible, to assess their accuracy

Outcome Measures

Primary Outcome Measures

  • The presence of dysplasia in a mucosal biopsy taken at follow up colonoscopy at 4-12 months
  • The presence of hypermethylation and dysplasia in a mucosal biopsy taken at follow up colonoscopy at 4-12 months

Secondary Outcome Measures

  • Complications during or following colonoscopy

Trial Design

 

 

ENDCaP-C trial design