Colorectal CancerColonoScopyNCT05172713
Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test
An observational study of Colorectal Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2021to 16 Apr 2022
- 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: Subject aged between 50 and 75 years old at the time of the colonoscopy with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
Who may be able to join
- Age between 50 and 75 years old at the time of the colonoscopy
- With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
- Patient whose follow-up has ended
- Patient living in the Grand-Est region and in the department of the site concerned
- Examination carried out by a gastroenterologist from the Grand-Est region
- Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Who cannot join
- Age ≥ 76 years at the time of colonoscopy
- Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
- Colonoscopy performed before the fecal immunological test
- Gastroenterologist performing the examination practicing outside the Grand-Est region
- Subject not able to understand the objectives of this research
- Subject under judicial control
- Subject under tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Jean-Marie REIMUND, MD, PhD, 33 3 88 12 74 41, jean-marie.reimund@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est
In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Immunological test, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test
Measured: Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start16 Jan 2021
- Primary completionApr 2022 (estimated)
- Study completion16 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172713
- Sponsor's protocol ID
- 8090
- Acronym
- ColonoScopy
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est
- ClinicalTrials.gov ID
- NCT05172713
- Acronym / sponsor ID
- ColonoScopy / 8090
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Immunological test, Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- 16 Apr 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- 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.
In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject aged between 50 and 75 years old at the time of the colonoscopy with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
Key inclusion criteria (6 listed)
- Age between 50 and 75 years old at the time of the colonoscopy
- With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
- Patient whose follow-up has ended
- Patient living in the Grand-Est region and in the department of the site concerned
- Examination carried out by a gastroenterologist from the Grand-Est region
Key exclusion criteria (7 listed)
- Age ≥ 76 years at the time of colonoscopy
- Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
- Colonoscopy performed before the fecal immunological test
- Gastroenterologist performing the examination practicing outside the Grand-Est region
- Subject not able to understand the objectives of this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test
Time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
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 University Hospital, Strasbourg, France 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 6 inclusion and 7 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 29 Dec 2021. 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 Jean-Marie REIMUND, MD, PhD (33 3 88 12 74 41, jean-marie.reimund@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test (time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]). 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 29 Dec 2021.