Colorectal cancer Cancer
Conditions
Interventions
The subjects will be required to undergo the CCE examination in the hospital endoscopy unit, where they will be monitored following the swallowing of the capsule. Participating subjects may have the o
Sponsors
AOU Città della Salute e della Scienza (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the potential role of CCE as a primary screening test or as a triage test to select subjects who need to be referred for colonoscopy assessment and eventually polypectomy 2. To assess CCE sensitivity and specificity by location (distal versus proximal colon) of advanced adenomas and CRC 3. Per-polyp analysis 4. The feasibility and organizational impact of the QUICK view reading in the interval between capsule egestion and the start of the OC examination, when using capsule as a triage test for colonoscopy referral Based on the exams database, issues related to reading reliability and quality can be assessed as well: 1. The accuracy of a reading strategy which would involve stopping the CCE film review as soon as the positivity criterion has been met (i.e., a polyp of the pre-specified size has been visualised), to simulate a possible feasible and efficient approach in a screening context 2. The accuracy and reproducibility of the reading when performed by gastroenterologists, other physicians (non-gastroenterologists) and nurses 3. The validation of the QUICK view reading modality as compared to the standard complete film reading; 20% QV will be used to learn about future opportunities of QUICK view | — |
Countries
Italy
Outcome results
None listed