Colon AdenomaNCT03690297
Linked Color Imaging (LCI) for Colorectal Adenoma Detection
A study testing Linked Color Imaging in people with Colon Adenoma and Colonic Polyp, run by Valduce Hospital at 1 site in Italy.
Trial summary
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. Read more about this study
- Who is it for?
- Ages 50 to 72 years
- Conditions the study is for
- Colon Adenoma, Colonic Polyp
- What is being tested?
- Linked Color Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2018to 1 Sep 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)
Who cannot join
- subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease)
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment)
- patients with previous colonic resection
- patients on antithrombotic therapy, precluding polyp resection
- patients who were not able or refused to give informed written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection
Read the detailed description
50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo).
The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
- Conditions
- Colon Adenoma, Colonic Polyp
- Being tested
- Linked Color Imaging
- Keywords
- adenoma detection rate, Linked Color Imaging, colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linked Color ImagingDevice
Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| LCI | Experimental | Linked Color Imaging Receives: Device: Linked Color Imaging |
| WL | Active comparator | White Light Receives: Device: Linked Color Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
proportion of participants with at least one adenoma (per-patient analysis)
Measured: 1 year
Secondary outcomes (3)
advanced adenoma detection rate
proportion of participants with at least one advanced adenoma
Measured: 1 year
mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions
total number of detected lesions in each group divided by the total number of participants
Measured: 1 year
Withdrawal time
time for mucosal inspection only
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 Oct 2018
- Primary completion21 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
- Investigators
- Franco Radaelli, MD, Principal investigator, Valduce Hospital, Como
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690297
- Sponsor's protocol ID
- 29052018_LCI
- Status last verified
- Oct 2019
- First submitted
- 18 Sep 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paggi S, Radaelli F, Senore C, Maselli R, Amato A, Andrisani G, Di Matteo F, Cecinato P, Grillo S, Sereni G, Sassatelli R, Manfredi G, Alicante S, Buscarini E, Canova D, Milan L, Pallini P, Iwatate M, Rondonotti E, Repici A, Hassan C. Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program. Gastrointest Endosc. 2020 Sep;92(3):723-730. doi: 10.1016/j.gie.2020.05.044. Epub 2020 Jun 2.
PubMed 32502550
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
- ClinicalTrials.gov ID
- NCT03690297
- Acronym / sponsor ID
- 29052018_LCI
- Conditions
- Colon Adenoma, Colonic Polyp
- Keywords
- adenoma detection rate, Linked Color Imaging, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 1 Oct 2018 (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.
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection
Detailed description
50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo).
The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCI | Experimental | Device: Linked Color ImagingLinked Color Imaging |
| WL | Active comparator | Device: Linked Color ImagingWhite Light |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)
Key exclusion criteria (5 listed)
- subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease)
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment)
- patients with previous colonic resection
- patients on antithrombotic therapy, precluding polyp resection
- patients who were not able or refused to give informed written consent.
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 |
|---|---|---|
| Linked Color ImagingUse of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy | Device | LCI, WL |
Primary outcome
Adenoma Detection Rate
Time frame: 1 year
proportion of participants with at least one adenoma (per-patient analysis)
3 secondary outcomes
advanced adenoma detection rate
Time frame: 1 year
mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions
Time frame: 1 year
Withdrawal time
Time frame: 1 year
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 2 Oct 2019.
- Derived from this study: PubMed 32502550Paggi S, Radaelli F, Senore C, Maselli R, Amato A, Andrisani G, Di Matteo F, Cecinato P, Grillo S, Sereni G, Sassatelli R, Manfredi G, Alicante S, Buscarini E, Canova D, Milan L, Pallini P, Iwatate M, Rondonotti E, Repici A, Hassan C. Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program. Gastrointest Endosc. 2020 Sep;92(3):723-730. doi: 10.1016/j.gie.2020.05.044. Epub 2020 Jun 2.
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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.
Franco Radaelli, MD principal investigator
Valduce Hospital, Como
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linked Color Imaging in people with Colon Adenoma and Colonic Polyp, run by Valduce Hospital at 1 site 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 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: finished, as of the sponsor's last update on 2 Oct 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 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?
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?
Adenoma Detection Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690297, which also lists 1 linked publication.
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 2 Oct 2019.