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Colorectal CancerIDYLICNCT02804802

Impact of DietarY and LIfestyle Risk Factors on Colorectal Cancer Screening

An observational study of Colorectal Cancer, run by University Hospital, Angers at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main purpose of our project is to construct a lifestyle score based on a short questionnaire easy to complete and to validate it among participants in mass screening for colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
questionnaire
How many people
49,000 participants
Where
1 siteFrance
Study dates
Feb 2013to Sep 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All participants in the organized screening for colorectal cancer over the next 2 years in the Maine-et-Loire department.

Who may be able to join

  • All participants in the organized screening for colorectal cancer over the next 2 years in the Maine-et-Loire department.

Who cannot join

  • Personal or family history of polyps or colorectal cancer
  • Personal history of bowel disease that already implies a surveillance by colonoscopy (inflammatory bowel syndrome, HNPCC, FAP)
  • Diseases with known genetic risk of developing colorectal cancer

Trial locations and contacts

1 site in 1 country.

François-Xavier Caroli-Bosc, MD PhD contact

+33241356054

FXCaroli-Bosc@chu-angers.fr

France1 site, 1 recruiting
  • François-Xavier CAROLI-BOSC

    Angers

    François-Xavier CAROLI-BOSC, MD PhD, FXCaroli-Bosc@chu-angers.fr

    Nathanaëlle Cornet, nathanaelle.cornet@chu-angers.fr

    Recruiting

Other trials in France

About this study

Official title: Impact of DietarY and LIfestyle Risk Factors on Colorectal Cancer Screening (IDYLIC Study). Is it Possible to Target Risk Subjects by Using a Predictive Score?

The main purpose of our project is to construct a lifestyle score based on a short questionnaire easy to complete and to validate it among participants in mass screening for colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive). Colorectal cancer will be the primary outcome for the assessment of the score's performance. The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our secondary objectives are to test a second weighting system, evaluate the benefit in terms of predictive performance to add to the lifestyle score other dietary factors among that have a probable link with the risk of colorectal cancer, determine the acceptability of the questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of targeted screening using the developed score.

Read the detailed description

Background: The clinical value of early detection of colorectal cancer has been clearly demonstrated. The evaluation in 23 pilot counties of the organized screening program for colorectal cancer in France, that was widespread throughout the country in 2009, concluded that results are satisfactory but should be improved especially in terms of sensitivity and participation rates. Epidemiological studies show that apart from the hereditary factor and age, the risk of colorectal cancer is mainly associated with lifestyle factors. The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) have published jointly in 2007 an update of the scientific knowledge on the relationships between nutritional factors (diet, physical activity) and the risk of cancer. This expert's report confirms that, according to the available data, the risk of colorectal cancer is increased in a convincing way with excessive consumption of alcohol, red meat and processed meat, and among overweight people, especially for those with excess abdominal adiposity. Conversely, the practice of regular physical activity has a protective effect. A recent meta-analysis estimated colorectal cancer relative risks of each of the factors mentioned above, smoking habits and other factors related to lifestyle (obesity, diabetes). This information helps to consider now the development of a predictive score for colorectal cancer.

Objectives: The main purpose of our project is to construct a lifestyle score based on a short questionnaire easy to complete and to validate it among participants in mass screening for colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive). Colorectal cancer will be the primary outcome for the assessment of the score's performance. The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our secondary objectives are to test a second weighting system, evaluate the benefit in terms of predictive performance to add to the lifestyle score other dietary factors among that have a probable link with the risk of colorectal cancer, determine the acceptability of the questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of targeted screening using the developed score.

Organization: The project will be coordinated by the department of Gastroenterology and Hepatology from Angers University Hospital. All data will be collected at the time of participation in organized screening program for colorectal cancer. The management of data collection will be done in close collaboration with the structure of screening in the Maine et Loire, Cap Santé 49, so as part of a logistic organization that is already operational. The identification of data that are specific to the project will be simplified by using for each participant the same barcode as that for Hemoccult test. To develop a questionnaire adapted to our objectives and a potential future use on large populations, we will rely on the expertise and experience of a French Research Unit in Nutritional Epidemiology (UMR U557 INSERM / INRA / CNAM / Paris XIII University). In recent years, this team has developed scores that assess compliance with the objectives or recommendations of the National Nutrition and Health Program. The Unit also developed a food frequency questionnaire adapted to the French population and has demonstrated the reproducibility and validity of this tool compared to repeated 24 hours dietary records. We will select from this questionnaire the items on the food groups that have an interest with the objectives of this project, our score will be constructed on the basis of consumption of foods or food groups, not nutrients. The statistical analysis will be conducted by the biostatisticians team from Angers University Hospital.

Expected results: The purpose of the tool (the questionnaire and the system for calculating the overall lifestyle score) is to help general practitioners to identify high risk subjects in general population, regardless of familial predisposition, and to encourage these people to participate in the national screening program. Associated with screening based on age, this strategy may optimize colorectal cancer screening in France.

Being tested
questionnaire
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaireOther

    dietary habits and physical activity questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (Hemoccult II)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startFeb 2013
  3. Primary completionJul 2016 (estimated)
  4. Study completionSep 2016 (estimated)

Resources

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
Prospective
Enrolment
49,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02804802
Sponsor's protocol ID
PHRC-K 2011
Acronym
IDYLIC
Status last verified
Jun 2016
First submitted
14 Jun 2016
Last updated
24 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by University Hospital, Angers 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 3 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 24 Jun 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 François-Xavier Caroli-Bosc, MD PhD (+33241356054, FXCaroli-Bosc@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colorectal cancer diagnosed by colonoscopy after a positive fecal occult blood test (Hemoccult II) (time frame: 1 year). 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 24 Jun 2016.

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