Colorectal CancerNCT00436514
Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
A study testing diet and absorption of ColoPEG, Colonoscopy with colic videocapsule and Standard colonoscopy in people with Colorectal Cancer, run by Nantes University Hospital at 1 site in France.
Trial summary
Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- diet and absorption of ColoPEG, Colonoscopy with colic videocapsule and Standard colonoscopy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jul 2009
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years
- patient able to give his informed consent
- No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
- No signs of stenosis of small intestine or colon
- No contraindication to anesthesia
- No participation to an other clinical study
- Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR
- Patient for who a endoscopic following is required because of familial cases or personal cases of polyps or colorectal cancer
Who cannot join
- Presence of symptoms evocating an occlusive pathology
- Recent complicated colic diverticulosis
- No informed consent
- pregnancy or no use of efficient contraception treatment
- Patient with a pace-maker or others internal medical electronic device
- Evolved nephric or cardiac insufficiencies
- Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient)
- Presence of a prolactinoma
Trial locations and contacts
1 site in 1 country.
About this study
Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.
- Conditions
- Colorectal Cancer
- Being tested
- diet and absorption of ColoPEG, Colonoscopy with colic videocapsule, Standard colonoscopy
- Keywords
- patients, medium risk, asymptomatic, between 50 and 74 years old, high risk, case, history of neoplastic colic, cancers, polyps
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and absorption of ColoPEGBehavioural
4l of PEG during 2 days
Colonoscopy with colic videocapsuleProcedure or surgery
2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative)
Standard colonoscopyProcedure or surgery
1l of PEG the morning just before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2009
- Study completionJul 2009
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 Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean Paul Galmiche, MD, Study director, Nantes University HospitalStanislas Chaussade, MD, Principal investigator, Hôpital CochinMarie-Georges Lapalus, MD, Principal investigator, Hospices Civils de LyonChristophe Cellier, MD, Principal investigator, CHU PompidouDenis Heresbach, MD, Principal investigator, Rennes University HospitalBernard Filoche, MD, Principal investigator, CH de Saint PhilibertVincent Maunoury, MD, Principal investigator, CHU de LilleGerard Gay, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436514
- Sponsor's protocol ID
- BRD 06/12-L
- Status last verified
- Jul 2009
- First submitted
- 16 Feb 2007
- Last updated
- 23 Jul 2009
- Results posted
- No
Publications
Sacher-Huvelin S, Coron E, Gaudric M, Planche L, Benamouzig R, Maunoury V, Filoche B, Frederic M, Saurin JC, Subtil C, Lecleire S, Cellier C, Coumaros D, Heresbach D, Galmiche JP. Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer. Aliment Pharmacol Ther. 2010 Nov;32(9):1145-53. doi: 10.1111/j.1365-2036.2010.04458.x. Epub 2010 Sep 16.
PubMed 21039676
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00436514
- Acronym / sponsor ID
- BRD 06/12-L
- Conditions
- Colorectal Cancer
- Keywords
- patients, medium risk, asymptomatic, between 50 and 74 years old, high risk, case, history of neoplastic colic, cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Feb 2007 (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.
Colorectal cancer is one of the most frequent and it prognosis is still serious. In France, diagnosis and screening applicated in numerous departements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Haemoccult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Haemoccult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitute an invasive method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasive method is required.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age between 18 and 80 years
- patient able to give his informed consent
- No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
- No signs of stenosis of small intestine or colon
- No contraindication to anesthesia
Key exclusion criteria (8 listed)
- Presence of symptoms evocating an occlusive pathology
- Recent complicated colic diverticulosis
- No informed consent
- pregnancy or no use of efficient contraception treatment
- Patient with a pace-maker or others internal medical electronic device
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 |
|---|---|---|
| diet and absorption of ColoPEG4l of PEG during 2 days | Behavioural | – |
| Colonoscopy with colic videocapsule2x 10mg Motilium, 2 Fleet Phospho soda (one is facultative) and 1 dulcolax (facultative) | Procedure or surgery | – |
| Standard colonoscopy1l of PEG the morning just before colonoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 23 Jul 2009.
- Derived from this study: PubMed 21039676Sacher-Huvelin S, Coron E, Gaudric M, Planche L, Benamouzig R, Maunoury V, Filoche B, Frederic M, Saurin JC, Subtil C, Lecleire S, Cellier C, Coumaros D, Heresbach D, Galmiche JP. Colon capsule endoscopy vs. colonoscopy in patients at average or increased risk of colorectal cancer. Aliment Pharmacol Ther. 2010 Nov;32(9):1145-53. doi: 10.1111/j.1365-2036.2010.04458.x. Epub 2010 Sep 16.
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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.
Jean Paul Galmiche, MD study director
Nantes University Hospital
Stanislas Chaussade, MD principal investigator
Hôpital Cochin
Marie-Georges Lapalus, MD 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?
A study testing diet and absorption of ColoPEG, Colonoscopy with colic videocapsule and Standard colonoscopy in people with Colorectal Cancer, run by Nantes University Hospital 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 8 inclusion and 8 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 23 Jul 2009. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00436514, 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 23 Jul 2009.