Linked Color Imaging (LCI) for Colorectal Adenoma Detection | NCT03690297

Studies
Linked Color Imaging (LCI) for Colorectal Adenoma Detection

NCT03690297

Sponsor

Valduce Hospital

Status

Completed

Last Update Posted

Oct 2, 2019Actual

Enrollment

600Actual

Phase

Not Applicable

Conditions

Colon Adenoma
Colonic Polyp

Interventions

Linked Color Imaging

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Jun 21, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Sep 18, 2018

First Submission Date that Met QC Criteria

Sep 27, 2018

First Posted Date

Oct 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2019

Last Update Posted Date

Oct 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Franco Radaelli, Principal Investigator, Head Endoscopy Unit, Valduce Hospital, Valduce HospitalPrincipal Investigator

Lead Sponsor

Valduce HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LCI	Experimental	Linked Color Imaging	Device: Linked Color Imaging
WL	Active Comparator	White Light	Device: Linked Color Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Linked Color Imaging	Device	Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy	LCI WL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma Detection Rate	proportion of participants with at least one adenoma (per-patient analysis)	1 year

Secondary Outcomes

Measure	Description	Time Frame
advanced adenoma detection rate	proportion of participants with at least one advanced adenoma	1 year
mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franco Radaelli, MD	Valduce Hospital, Como	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Unit, Valduce Hospital		Como		22100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32502550	Derived	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.

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms