Clinical trial NCT02558881: Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening
Official title: Evaluation of a Complementary Action of Recruitment of Patients With a Positive Screening Test and Not Realizing Optical Colonoscopy as Part of Organized Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: screening
colorectal cancer
colon capsule
virtual colonoscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 664
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a positive FOBT at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery.

Brief summary: France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008.

This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...).

Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy.

The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with a positive FOBT at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery

Exclusion Criteria:

* None

Primary outcomes:
measure: Acceptance rate of colonic capsule versus virtual colonoscopy.
timeFrame: A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person.
Secondary outcomes:
measure: Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.
timeFrame: 6 months
measure: Failure rate of examinations by cause
timeFrame: 6 months
measure: Diagnostic performance of virtual colonoscopy and colon capsule
timeFrame: 6 months
measure: Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule
timeFrame: 6 months
measure: Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
timeFrame: 6 months
measure: Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
timeFrame: 6 months
measure: Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
timeFrame: 6 months
measure: Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule
timeFrame: 6 months
measure: Additional costs generated by the implementation of a complementary action of screening for patients with a positive FOBT and did not realize optical colonoscopy
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopsices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Thierry PONCHON, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pioche M, Ganne C, Gincul R, De Leusse A, Marsot J, Balique J, Fond A, Bretagnolle M, Henry L, Billaud Y, Malezieux R, Lapalus MG, Chambon-Augoyard C, Del Tedesco E, Scalone O, Montoy JC, Russias B, Detry A, Veniat F, Qiu J, Valette PJ, Taillandier A, Saurin JC, Tomczyk-Ferrero J, Gandilhon C, Vecchiato L, Soler-Michel P, Ponchon T. Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial. Endoscopy. 2018 Aug;50(8):761-769. doi: 10.1055/s-0044-100721. Epub 2018 Feb 27.