Colorectal Cancer Control and PreventionPROMOTENCT06775951
Appropriateness of Colonoscopy Indication: an Evaluation of the Clinical and Economic Impact.
An observational study of Colorectal Cancer Control and Prevention, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Control and Prevention
- How many people
- 1,410 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Jan 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participating subjects will undergo data collection at the same time as colonoscopy. After enrollment, information will be collected for each included patient regarding the demographic and clinical characteristics, the reason for prescription, and the diagnostic question proposed in congruity with EPAGE/ASGE criteria.
Who may be able to join
- Age >18 years
- Patients undergoing outpatient and inpatient colonoscopy for any pathology, as part of the normal care process
- Obtaining informed consent.
Who cannot join
- Investigations performed in an emergency/emergency setting
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Lorenzo Fuccio, MD, 0512143338, lorenzo.fuccio@aosp.bo.it
About this study
Official title: Appropriateness of Colonoscopy Indication: an Evaluation of the Clinical and Economic Impact. Multicenter Prospective Observational Study.
The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.
Read the detailed description
Colonoscopy is the most frequently conducted endoscopic examination in industrialized countries, occupying a considerable number of personnel and resources. However, colonoscopy is often over-prescribed, resulting in great waste of resources and increased risk to the patient with no discernible benefit. Colonoscopy has many indications and needs precise prescribing criteria to avoid inappropriate use of resources, especially in an open-access health care system such as the Italian one, criteria recently systematized by EPAGE (European Panel for Appropriateness in Gastrointestinal Endoscopy) and ASGE (American Society for Gastrointestinal Endoscopy) based on a set of observational studies. In these studies, it has been shown that colonoscopies with an appropriate indication frequently find significant lesions compared with colonoscopies prescribed according to inappropriate criteria, which are often negative. The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.
- Conditions
- Colorectal Cancer Control and Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Data collection for each patient on endoscopic examination | Data collection in patients undergoing colonoscopy, to identify the ability of the predictive model to predict colonoscopies with significant diagnostic findings, in patients already initiated for diagnostic examination as part of the normal care pathway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of colonoscopies
Define the number of colonoscopies with indication appropriate out of the total number of colonoscopies performed, and quantify clinically relevant lesions and CCRs in appropriate and inappropriate colonoscopies.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start2 Jan 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Prospective
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Fuccio, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775951
- Sponsor's protocol ID
- PROMOTE
- Acronym
- PROMOTE
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Colonoscopy Indication: an Evaluation of the Clinical and Economic Impact. Multicenter Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06775951
- Acronym / sponsor ID
- PROMOTE / PROMOTE
- Conditions
- Colorectal Cancer Control and Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.
Detailed description
Colonoscopy is the most frequently conducted endoscopic examination in industrialized countries, occupying a considerable number of personnel and resources. However, colonoscopy is often over-prescribed, resulting in great waste of resources and increased risk to the patient with no discernible benefit. Colonoscopy has many indications and needs precise prescribing criteria to avoid inappropriate use of resources, especially in an open-access health care system such as the Italian one, criteria recently systematized by EPAGE (European Panel for Appropriateness in Gastrointestinal Endoscopy) and ASGE (American Society for Gastrointestinal Endoscopy) based on a set of observational studies. In these studies, it has been shown that colonoscopies with an appropriate indication frequently find significant lesions compared with colonoscopies prescribed according to inappropriate criteria, which are often negative. The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection for each patient on endoscopic examination | – | –Data collection in patients undergoing colonoscopy, to identify the ability of the predictive model to predict colonoscopies with significant diagnostic findings, in patients already initiated for diagnostic examination as part of the normal care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participating subjects will undergo data collection at the same time as colonoscopy. After enrollment, information will be collected for each included patient regarding the demographic and clinical characteristics, the reason for prescription, and the diagnostic question proposed in congruity with EPAGE/ASGE criteria.
Key inclusion criteria (3 listed)
- Age >18 years
- Patients undergoing outpatient and inpatient colonoscopy for any pathology, as part of the normal care process
- Obtaining informed consent.
Key exclusion criteria (1 listed)
- Investigations performed in an emergency/emergency setting
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
Number of colonoscopies
Time frame: 5 months
Define the number of colonoscopies with indication appropriate out of the total number of colonoscopies performed, and quantify clinically relevant lesions and CCRs in appropriate and inappropriate colonoscopies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
Lorenzo Fuccio, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites 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 Control and Prevention, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Fuccio, MD (0039 0512143338, lorenzo.fuccio3@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of colonoscopies (time frame: 5 months). 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 15 Jan 2025.