Brief Summary

The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

426

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach

3 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

First Submitted

Initial submission to the registry

November 13, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed

10 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed

Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

November 13, 2018

Last Update Submit

September 20, 2023

Conditions

Colorectal Cancer Colorectal Polyp

Keywords

EndoscopyColonoscopyInvasive patternPolypectomyNBIBLIDeep submucosal invasionJNETKudo pit pattern

Outcome Measures

Primary Outcomes (3)

The presence or absence of deep invasion according to the control test (WLE)
Deep invasion will subjectively be diagnosed based on the presence of gross morphological malignant features, morphology and size. No single malignant feature, specific morphology or size is required. The importance given to each criterion and the final diagnosis of deep invasion is based on the personal experience of the endoscopist.
One day
The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE)
Deep invasion will be diagnosed in case of: * JNET type 3 or * JNET 2B + Kudo Vn pit pattern or * JNET 2B and Kudo Vi pit pattern fulfilling all the following criteria: severe Kudo Vi pit pattern + presence of a demarcated area + size (demarcated area) \>6 mm for PG or 3 mm for NPG.
One day
The presence or absence of deep invasion according to the gold standard (histology)
Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.
One day

Secondary Outcomes (2)

Presence of any genetic mutations
one day
Number of genome copies using SNP-arrays
one day

Study Arms (1)

Patients with colorectal polyps

Patients with non-pedunculated type 0 lesions in Paris classification (not obvious cancers) larger than 10 mm

Diagnostic Test: White light endoscopy (WLE)Diagnostic Test: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)

Interventions

White light endoscopy (WLE)DIAGNOSTIC_TEST

Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.

Patients with colorectal polyps

NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)DIAGNOSTIC_TEST

Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.

Patients with colorectal polyps

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Consecutive patients \> 18 years old who undergo a colonoscopy for any reason

You may qualify if:

Non-pedunculated type 0 lesions in Paris classification (not obvious cancers)
Lesions larger than 10 mm

You may not qualify if:

Lesions assessed as JNET 1 by the endoscopist or serrated by the pathologist
Previous biopsy or resection attempt
Previous CT, MR or USE
Unavailable histology
Inflammatory bowel disease
Informed consent not obtained
Protocol violation

Contact the study team to confirm eligibility.

Study Sites (14)

San Francisco Veterans Affairs Medical Center. University of California

San Francisco, California, 94121, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

National Cancer Center

Tokyo, 104-0045, Japan

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitari Germans Trias i Pujol (Can Ruti)

Badalona, Catalonia, 08916, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

Barcelona, Catalonia, 08036, Spain

Location

Althaia. Xarxa Assistencial Universitària de Manresa

Manresa, Catalonia, 08243, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Comarcal de Alcañiz

Alcañiz, Teruel, 44600, Spain

Location

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, 46009, Spain

Location

Centro Médico Teknon

Barcelona, 08022, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (4)

Backes Y, Moss A, Reitsma JB, Siersema PD, Moons LM. Narrow Band Imaging, Magnifying Chromoendoscopy, and Gross Morphological Features for the Optical Diagnosis of T1 Colorectal Cancer and Deep Submucosal Invasion: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2017 Jan;112(1):54-64. doi: 10.1038/ajg.2016.403. Epub 2016 Sep 20.
PMID: 27644737BACKGROUND
Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.
PMID: 23910062BACKGROUND
Sano Y, Tanaka S, Kudo SE, Saito S, Matsuda T, Wada Y, Fujii T, Ikematsu H, Uraoka T, Kobayashi N, Nakamura H, Hotta K, Horimatsu T, Sakamoto N, Fu KI, Tsuruta O, Kawano H, Kashida H, Takeuchi Y, Machida H, Kusaka T, Yoshida N, Hirata I, Terai T, Yamano HO, Kaneko K, Nakajima T, Sakamoto T, Yamaguchi Y, Tamai N, Nakano N, Hayashi N, Oka S, Iwatate M, Ishikawa H, Murakami Y, Yoshida S, Saito Y. Narrow-band imaging (NBI) magnifying endoscopic classification of colorectal tumors proposed by the Japan NBI Expert Team. Dig Endosc. 2016 Jul;28(5):526-33. doi: 10.1111/den.12644. Epub 2016 Apr 20.
PMID: 26927367BACKGROUND
Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
PMID: 30296432BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin blocks of colorectal polyps

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

Ignasi Puig, MD, PhD
Althaia Xarxa Assistencial Universitària de Manresa
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Gastroenterology consultant, MD, PhD

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 21, 2018

Study Start

December 1, 2018

Primary Completion

September 28, 2022

Study Completion

October 30, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing: Will not share

Locations

ES(11)US(2)JP(1)

Accuracy for Predicting Deep Submucosal Invasion

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

Patients with colorectal polyps

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (4)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

Patients with colorectal polyps

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (4)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations