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Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening (COCAGI)

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ClinicalTrials.gov Identifier: NCT02558881
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Virtual colonoscopy Procedure: Colon capsule

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Study Type : Observational
Actual Enrollment : 664 participants
Observational Model: Case Control
Time Perspective: Prospective
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 Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Virtual colonoscopy
With virtual colonoscopy, the patient does not need to be hospitalized for examination, which is usually done without hospitalization. A bowel preparation is necessary. It may vary from site to site, but it generally comprises polyethylene glycol or sodium phosphate. The residual stools are "marked" by ingestion of a radiopaque product to differentiate colic lesions. But no contrast agent is injected intravenously. The patient should be supine and a rectal probe is set up to inject either air or CO2. The vesting period does not exceed thirty seconds apnea, and overall completion time of the examination (patient table) is about 10 minutes.
Procedure: Virtual colonoscopy
Colon capsule
The colon capsule comprises two cameras located at both ends. Image acquisition is set between four to thirty-five images per second. It begins immediately after ingestion of the capsule which allows recording of esophageal and gastric images. She paused for 2 hours (to save batteries) while crossing the small intestine. It is reactivated in the terminal ileum. The films analysis time is approximately 1 hour, and the capsule remains on average 3 hours in the colon.
Procedure: Colon capsule



Primary Outcome Measures :
  1. Acceptance rate of colonic capsule versus virtual colonoscopy. [ Time Frame: A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person. ]
    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


Secondary Outcome Measures :
  1. Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa. [ Time Frame: 6 months ]
  2. Failure rate of examinations by cause [ Time Frame: 6 months ]
    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 ...)

  3. Diagnostic performance of virtual colonoscopy and colon capsule [ Time Frame: 6 months ]
    Percentage of patients with suspected colorectal neoplastic lesions

  4. Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule [ Time Frame: 6 months ]
    Percentage of patients who achieve an optical colonoscopy after suspected neoplastic colorectal lesion

  5. Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]
    Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter

  6. Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]
    Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter

  7. Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps [ Time Frame: 6 months ]
    Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter

  8. Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule [ Time Frame: 6 months ]
  9. Additional costs generated by the implementation of a complementary action of screening for patients with a positive FOBT and did not realize optical colonoscopy [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT02558881


Locations
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France
Hopsices Civils de Lyon
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Thierry PONCHON, Professor Hospices Civils de Lyon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02558881     History of Changes
Other Study ID Numbers: 2012-757
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Hospices Civils de Lyon:
screening
colorectal cancer
colon capsule
virtual colonoscopy

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases