Cancer ColorectalISIRECCNCT02931825
Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System
A study testing Reminder letter in people with Cancer Colorectal, run by University Hospital, Tours at 1 site in France.
Trial summary
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Reminder letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,101 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2017to 23 May 2019
- 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- residing in Indre et Loire (France)
- with increased risk for colorectal cancer
- who did not perform a colonoscopy in the past 58 months
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.
The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer
Read more
The project will be divided into 2 phases:
Objectives of the first phase:
- Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
- Fill in as completely as possible their colonoscopic history in the past 5 years,
- Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).
Objective of the second phase:
Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.
- Conditions
- Cancer Colorectal
- Being tested
- Reminder letter
- Keywords
- high risk, surveillance, screening, colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder letterBehavioural
The letter will consist in several parts:
- Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years)
- Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up
- Request information if they've done their follow-up or if we have incorrect information
- Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer
| Study group | Role | What they receive |
|---|---|---|
| Reminder letter | Experimental | A letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time). Receives: Behavioral: Reminder letter |
| Control | No intervention | No intervention (what is done currently) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)
Measured: one year
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
Measured: 12 months after sending the letter (/randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start23 May 2017
- Primary completion23 May 2018
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somany SENGCHANH, Dr, Principal investigator, Centre de Coordination des Dépistages des Cancers CHRU de ToursKen HAGUENOER, Dr, Principal investigator, Centre de Coordination des Dépistages des CancersJulie Boyard, Principal investigator, Centre de Coordination des Dépistages des CancersThierry Lecomte, Pr, Study chair, CHRU de Tours, Service Hépato- gastroentérologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931825
- Sponsor's protocol ID
- INCa15-SS/ISIRECC
- Other IDs
- 2015-A01607-42
- Acronym
- ISIRECC
- Status last verified
- May 2019
- First submitted
- 11 Oct 2016
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening
- ClinicalTrials.gov ID
- NCT02931825
- Acronym / sponsor ID
- ISIRECC / INCa15-SS/ISIRECC
- Conditions
- Cancer Colorectal
- Keywords
- high risk, surveillance, screening, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,101 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 13 Oct 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.
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.
The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer
The project will be divided into 2 phases:
Objectives of the first phase:
- Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
- Fill in as completely as possible their colonoscopic history in the past 5 years,
- Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).
Objective of the second phase:
Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminder letter | Experimental | Behavioral: Reminder letterA letter is sent for remind the importance of compliance with colonoscopy AND to encourage people to to consult their general practitioner or gastroenterologist (if they haven't done their follow-up in time). |
| Control | No intervention | –No intervention (what is done currently) |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- residing in Indre et Loire (France)
- with increased risk for colorectal cancer
- who did not perform a colonoscopy in the past 58 months
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 |
|---|---|---|
| Reminder letterThe letter will consist in several parts: * Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years) * Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up * Request information if they've done their follow-up or if we have incorrect information * Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer | Behavioural | Reminder letter |
Primary outcome
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)
Time frame: one year
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms
Time frame: 12 months after sending the letter (/randomization)
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 30 May 2019.
- Individual participant dataSharing planned: No
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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.
Somany SENGCHANH, Dr principal investigator
Centre de Coordination des Dépistages des Cancers CHRU de Tours
Ken HAGUENOER, Dr principal investigator
Centre de Coordination des Dépistages des Cancers
Julie Boyard principal investigator
Centre de Coordination des Dépistages des Cancers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder letter in people with Cancer Colorectal, run by University Hospital, Tours 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 3 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 30 May 2019. 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?
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years) (time frame: one year). The study lists 2 primary outcomes in all. 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 30 May 2019.