Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

— COCAGI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558881
• Other study ID #: 2012-757
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: September 23, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Virtual colonoscopy

• Colon capsule

Locations

Country	Name	City	State
France	Hopsices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance rate of colonic capsule versus virtual colonoscopy.	Acceptance is defined by the fact that a person having made an appointment for one of the two exams and he went to the review	A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person.	No
Secondary	Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.		6 months	No
Secondary	Failure rate of examinations by cause	Percentage of bad colic preparations, percentage against-indications, complication rate, percentage capsules have not been to the end of the colon, percentage of other causes (eg. technical ...)	6 months	No
Secondary	Diagnostic performance of virtual colonoscopy and colon capsule	Percentage of patients with suspected colorectal neoplastic lesions	6 months	No
Secondary	Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule	Percentage of patients who achieve an optical colonoscopy after suspected neoplastic colorectal lesion	6 months	No
Secondary	Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps	Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter	6 months	No
Secondary	Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps	Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter	6 months	No
Secondary	Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps	Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter	6 months	No
Secondary	Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule		6 months	No
Secondary	Additional costs generated by the implementation of a complementary action of screening for patients with a positive FOBT and did not realize optical colonoscopy	The costs taken into account will be the direct medical costs of two exams, as well as non-medical direct costs: 1) Letters of invitation to perform any of the tests, 2) Examination conducted (colon capsule or virtual colonoscopy), 3) Letters of Transmittal results	6 months	No