Assessing accuracy of PillCam Colon 2 in a screening setting: a prospective study in Italy

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN62158762
• Lead Sponsor: AOU Città della Salute e della Scienza (Italy)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/31629719/ (added 01/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-08
• Study Completion: 2015-06-30
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

Subjects aged 55 to 69, undergoing FIT for the first time in the context of the local population-based colorectal cancer (CRC) screening program, or those aged 60 to 69, having performed a previous test in the program, referred for OC following a positive test result, who will give their consent to be enrolled in the study

Exclusion Criteria

In addition to the exclusion criteria already adopted by the population screening progammes (i.e., personal history of CRC or adenomas, or inflammatory bowel disease, hereditary syndromes [familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC)], inability to provide informed consent, severe life-threatening disease), the presence of any of the following will exclude a subject from study enrollment:
1. Dysphagia or any swallowing disorder
2. Congestive heart failure
3. High degree of renal failure
4. Prior abdominal surgery of the gastrointestinal tract, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
5. Symptoms suggestive for sub-occlusion
6. History of negative large bowel endoscopy within the previous 5 years
7. Cardiac pacemaker or other implanted electro-medical device
8. Any allergy or other known contraindication to the medications used in the study. In particular history of allergic reactions after administration of iodine contrast media and history of thyroid disorders will represent a criterion for exclusion
9. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule
10. Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumours, previous history of abdominal or pelvic radiotherapy, or NSAID enteropathy
11. Any condition which precludes compliance with study and/or device instructions
12. Subject currently participating in another clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main aim of the study is to assess the accuracy (sensitivity and specificity) and the positive and negative predictive value (PPV and NPV) of PillCam Colon 2, compared to conventional colonoscopy, in detecting CRC and advanced adenomas, among subjects with a positive FIT, attending in an organised population screening programme. The primary goal will be to assess, on a per-patient basis, the accuracy and predictive values of two different positivity thresholds for OC referral (i.e., criteria for defining a positive CCE exam): identification of least one lesion = 6 mm , or of at least one lesion = 10 mm. We will also assess these same parameters when using intermediate thresholds for CCE-detected lesions (i.e., lesions = 7 , 8, 9 mm) in order to get information to estimate the optimal positivity cut-off.