Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Performance and Evaluation for CT Colonography Screening (PERFECTS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892721
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
University College London Hospitals
Information provided by (Responsible Party):
London North West Healthcare NHS Trust

Brief Summary:

Colorectal cancer (CRC) is an important United Kingdom healthcare issue affecting 1 in 20 individuals, half of whom will die from the disease. Late presentation of CRC has a poor prognosis, whereas excellent cure rates (>95%) are seen in those who present early. Accurate and early diagnosis of CRC is therefore crucial. In most patients this is achieved via colonoscopy, a camera test which is widely available and allows tissue samples to be taken of any abnormalities seen during the procedure. However, a non-invasive alternative is Computed Tomography Colonography (CTC) which uses X-rays to produce images of the large bowel which are then interpreted by Radiologists. CTC has high sensitivity for the diagnosis of CRC (comparable to colonoscopy) and the cancer precursor - adenomatous polyps.

Unlike colonoscopy, however, there is no accreditation process for CTC and there is no infrastructure to ensure that all reporting Radiologists are able to do so adequately and, as a result, there is a wide range of diagnostic accuracy. There are no universally-accepted standards to monitor quality or assess diagnostic performance, partly because we do not know what the quality markers are and there is currently no system to quantify them. Overall, this contributes to low cancer detection rates, missed cancers and inequity for patients across the National Health Service (NHS).

This study aims to assess the impact of a structured training programme with assessment and feedback on NHS radiologist performance. If the impact is positive and results in significantly improved performance, then such a scheme could be adopted into an accreditation programme for CTC in the English Bowel Cancer Screening Programme (BCSP).


Condition or disease Intervention/treatment Phase
Colonic Neoplasms Colorectal Neoplasms Other: Training with feedback Not Applicable

Detailed Description:

CT Colonography is a test which can can detect early cancer accurately, however, unlike colonoscopy (or mammography in breast cancer screening) there is currently no formalised program to help ensure Radiologists interpret CTC accurately. Colonoscopists are highly regulated, must be accredited and have ongoing quality assurance metrics, based on evidence linking these to clinical outcomes. Conversely, for CTC in the United Kingdom, there is no accreditation process, little regulatory oversight and no universally-accepted metrics to monitor quality or diagnostic performance.

Radiologists who interpret CTC images are often inexperienced; one-third have interpreted <300 cases in total and 20% report <100 cases per annum (the minimum recommendation). Futhermore, in clinical practice across the NHS Bowel Cancer Screening Programme (NHS BCSP) CTC may have up to a 50% lower cancer and polyp detection rate than colonoscopy. Missed abnormalities at CTC are likely to underpin this difference, as centres with highly experienced radiologists (>1000 cases) using 3-dimensional interpretation have significantly higher detection rates.

There is a Quality Assurance (QA) framework for the NHS BCSP (with an overseeing QA Committee for Radiology) but recommendations are largely based on opinion rather than evidence and any radiologist can report CTC, without accreditation; a fact which our patient representatives find extremely disappointing.

Prior to wide-scale implementation of a possible accreditation programme and to justify both financial and human resource, Public Health England and the British Society of Gastrointestinal and Abdominal Radiologists have mandated that such a program is scientifically proven to improve Radiologist performance. Consequently, this project will investigate training and assessment methods to improve diagnostic accuracy and elucidate the factors associated with higher Radiologist sensitivity.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Performance and Evaluation for CT Colonography Screening
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 31, 2020

Arm Intervention/treatment
No Intervention: Control group
The control group will not receive the one-day training course or access to the online educational module. Test sets will be administered in the same manner as for the intervention group, but the control group will not receive any feedback on performance during the 12 month assessment phase. Feedback on test performance will only be provided after the 12 month period has ended.
Training with feedback
See intervention description
Other: Training with feedback

One-day workshop of face to face training, comprising a mixture of theory and real-world CTC cases. Radiologists will complete four interpretation assessments lasting 2 to 3 hours: one set of 10 CTC cases immediately prior to training and a further test set of 10 immediately after, with tests repeated at 6 and 12 months (using different CTC cases for each set). Radiologists will be asked to identify colorectal cancer and polyps on the scans and complete an online answer form, including questions regarding diagnostic confidence, site of abnormality and management.

The intervention group will receive online, confidential, individualised feedback after each test, which will include a case by case breakdown of their performance with explanatory answers and learning points.





Primary Outcome Measures :
  1. Difference in sensitivity between arms [ Time Frame: One month after intervention ]
    Difference in sensitivity between intervention and control groups for detection of colorectal cancer / polyps on CT colonography at the 1 month post-intervention test.


Secondary Outcome Measures :
  1. Difference in sensitivity between intervention and controls for colorectal cancer/ polyps at the 12 month post-training test set (i.e. to test longer-term durability of one-off training supplemented by individualized feedback). [ Time Frame: Twelve months after intervention ]
  2. Difference in specificity between intervention and controls at 1 month. [ Time Frame: One month after intervention ]
  3. Difference in specificity between intervention and controls at 12 months. [ Time Frame: Twelve months after intervention ]
  4. Difference in sensitivity between intervention and controls at 6 months. [ Time Frame: Six months after intervention ]
  5. Difference in specificity between intervention and controls at 6 months. [ Time Frame: Six months after intervention ]
  6. Difference in raw score between the control and intervention arms on the knowledge questions as compared to true answers. [ Time Frame: 1 month after intervention ]
  7. Association between interpretation time and diagnostic performance of radiologists on all test sets. [ Time Frame: 12 months after intervention and after final test set. ]
  8. Characteristics of radiologists performing well versus those that do not. [ Time Frame: After the final test set at 12 months ]


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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • National Health Service (NHS) Consultant Radiologists or final year Registrars or Fellows in the England or Wales who currently routinely report CT colonography scans.

Exclusion Criteria:

  • Radiologists who do not routinely report CT colonography scans.

This study is limited to NHS staff and does not involve any patients.


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 ClinicalTrials.gov identifier (NCT number): NCT02892721


Locations
Layout table for location information
United Kingdom
LNW Healthcare NHS Trust
Harrow, Middlx, United Kingdom, HA1 3UJ
Sponsors and Collaborators
London North West Healthcare NHS Trust
University College London Hospitals
Investigators
Layout table for investigator information
Study Director: Andrew Plumb, FRCR University College London Hospitals
Publications:

Layout table for additonal information
Responsible Party: London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02892721    
Other Study ID Numbers: RD16/055
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised participant data will be included in the research analysis.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London North West Healthcare NHS Trust:
CT Colonography
Virtual colonoscopy
Colorectal cancer
Colon cancer
Training
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases