Colorectal CancerCOCAGINCT02558881
Colon Capsule Versus Virtual Colonoscopy for Colorectal Cancer Screening
An observational study of Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
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%. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Virtual colonoscopy and Colon capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 664 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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...).
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Virtual colonoscopy, Colon capsule
- Keywords
- screening, colorectal cancer, colon capsule, virtual colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual colonoscopyProcedure or surgery
Colon capsuleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Colon capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person.
Secondary outcomes (9)
Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.
Measured: 6 months
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 ...)
Measured: 6 months
Diagnostic performance of virtual colonoscopy and colon capsule
Percentage of patients with suspected colorectal neoplastic lesions
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PONCHON, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558881
- Sponsor's protocol ID
- 2012-757
- Acronym
- COCAGI
- Status last verified
- Sep 2015
- First submitted
- 18 Sep 2015
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29486502
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02558881
- Acronym / sponsor ID
- COCAGI / 2012-757
- Conditions
- Colorectal Cancer
- Keywords
- screening, colorectal cancer, colon capsule, virtual colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual colonoscopy | – | Procedure: Virtual colonoscopyWith 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. |
| Colon capsule | – | Procedure: Colon capsuleThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual colonoscopy | Procedure or surgery | Virtual colonoscopy |
| Colon capsule | Procedure or surgery | Colon capsule |
Primary outcome
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
9 secondary outcomes
Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.
Time frame: 6 months
Failure rate of examinations by cause
Time frame: 6 months
Diagnostic performance of virtual colonoscopy and colon capsule
Time frame: 6 months
Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule
Time frame: 6 months
Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
Time frame: 6 months
Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
Time frame: 6 months
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
Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Derived from this study: PubMed 29486502Pioche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PONCHON, Professor principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.