Colorectal AdenomaDACCORNCT02859714
Detection of Colorectal Adenomas in Côte-d'Or
An observational study of Colorectal Adenoma, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- screening data
- How many people
- 11,600 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Jan 2017
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008.
Who may be able to join
- The study population will include all patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008
Who cannot join
- Absence of address
- history (or suspected history) of previously resected adenoma
- personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy)
- familial polyposis or known HNPCC
- chronic inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Dijon Bourgogne
Dijon, 21079
Vanessa COTTET, 03.80.39.34.87, vanessa.cottet@chu-dijon.fr
About this study
Official title: Detection of Colorectal Adenomas in Côte-d'Or: Impact of Organized Screening on Socio-geographic Disparities
Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.
- Conditions
- Colorectal Adenoma
- Being tested
- screening data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening dataOther
| Study group | Role | What they receive |
|---|---|---|
| colorectal adenoma | Not described Receives: Other: screening data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rates for colorectal adenomas
Measured: through the study completion up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859714
- Sponsor's protocol ID
- COTTET PARI 2015
- Acronym
- DACCOR
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Colorectal Adenomas in Côte-d'Or: Impact of Organized Screening on Socio-geographic Disparities
- ClinicalTrials.gov ID
- NCT02859714
- Acronym / sponsor ID
- DACCOR / COTTET PARI 2015
- Conditions
- Colorectal Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Primary completion
- Jan 2017 (estimated)
- First posted
- 9 Aug 2016 (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.
Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal adenoma | – | Other: screening data |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008.
Key inclusion criteria (1 listed)
- The study population will include all patients residing in Côte d'Or with a first colorectal adenoma (including in situ carcinomas) diagnosed between 01/01/1997 and 31/12/2008
Key exclusion criteria (5 listed)
- Absence of address
- history (or suspected history) of previously resected adenoma
- personal history of colorectal cancer or colorectal cancer discovered in the year following resection of the adenoma (because the cancer was probably not seen at the initial colonoscopy)
- familial polyposis or known HNPCC
- chronic inflammatory bowel disease
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 |
|---|---|---|
| screening data | Other | colorectal adenoma |
Primary outcome
Detection rates for colorectal adenomas
Time frame: through the study completion up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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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.
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 Adenoma, run by Centre Hospitalier Universitaire Dijon 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 5 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa COTTET (03.80.39.34.87 ext. 33, vanessa.cottet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rates for colorectal adenomas (time frame: through the study completion up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.