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Accuracy for Predicting Deep Submucosal Invasion (NBIBLI)

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ClinicalTrials.gov Identifier: NCT03748667
Recruitment Status : Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Hospital Universitario La Fe
Hospital Clínico Universitario Lozano Blesa
University of North Carolina, Chapel Hill
Hospital Clinic of Barcelona
National Cancer Center, Japan
Germans Trias i Pujol Hospital
Hospital Universitario 12 de Octubre
Complejo Hospitalario de Navarra
Hospital Universitario Ramon y Cajal
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Ignasi Puig del Castillo, Althaia Xarxa Assistencial Universitària de Manresa

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.

Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Polyp Diagnostic Test: White light endoscopy (WLE) Diagnostic Test: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)

Detailed Description:

A video with the lesion assessment, without any data on the patient, will be recorded in a device connected to the processor provided by the Principal Investigator. The name of the file will be the record ID. All the lesions will be tested by the same endoscopist in vivo and an assistant will fulfill the data collection sheet during the colonoscopy.

First, the lesions will be cleaned and observed in a stable position. Size, location, morphology, demarcated areas, and gross morphological malignant features will be evaluated. Based on these WLE characteristics, a deep invasion prediction will be performed (control test). Second, the lesion will be assessed using NBI with near focus or magnification or BLI with magnification. A second cleaning with pronase (or N-acetylcysteine if pronase is not available) if the surface cannot be clearly observed because of the presence of mucus or if crystal violet is going to be used. Crystal violet 0.05% will be used in case of polyps type 2B in the JNET classification or lesions with a demarcated area. A non-traumatic catheter (or spray catheter) will be used to spray the crystal violet over the lesion. A final prediction of deep invasion will be performed for NBI or BLI ± CE (test evaluated).

The use of a cap to observe the bottom of the lesion, fix the lesion close to the endoscope or to observe the lesion underwater immersion is strongly recommended.

The resection technique will be decided upon according to the local experience. In case of endoscopy resection (cold snare, EMR, ESD, full thickness), lesions will be removed via the anus (not through the endoscopy channel) in order to preserve their integrity. Although EMR is performed, if possible, lesions will be referred to the pathologist well oriented and pinned out on a cork based, as is standard procedure in ESD.

In order to ensure that endoscopic assessment is performed before the histology evaluation, both diagnostic assessments (control test and test evaluated) will be recorded on the REDCap database on the day of the colonoscopy. REDCap records the time and date of all changes in the variables' results. The remaining variables (demographic data, etc.) will be recorded on the data collection sheet and copied later into REDCap.

Videos of the lesion assessments will be sent to the Principal Investigator. Centralized visualization will be conducted to detect protocol violations and to exclude lesions from the study.

A blinded histology assessment will be conducted by the local pathologist and if a carcinoma with submucosal invasion is diagnosed, histology slides will be referred for an additional blinded and centralized histology evaluation at the end of the study.

Pathologists participating in the histological phase will assess all the slides with submucosal invasion and will collect the histological factors associated with lymph node metastasis.

Finally, investigators participating in the translational phase will refer paraffin blocks of 10 lesions of each JNET category (2A, 2B and 3) for genetic tests (sequencing of a panel of 45 genes and analysis of alterations in the number of copies of the genome).


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Study Type : Observational
Estimated Enrollment : 1158 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy of Deep Submucosal Invasion: White Light Endoscopy vs Invasive Pattern Based on NBI/BLI ± Chromoendoscopy
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
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)
Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.

Diagnostic Test: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)
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.




Primary Outcome Measures :
  1. The presence or absence of deep invasion according to the control test (WLE) [ Time Frame: One day ]
    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.

  2. The presence or absence of deep invasion according to the test evaluated (NBI/BLI +/- CE) [ Time Frame: One day ]

    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.

  3. The presence or absence of deep invasion according to the gold standard (histology) [ Time Frame: One day ]
    Deep invasion will be diagnosed if sm invasion ≥1000 μm is measured according to the Japanese guidelines by the central pathologists.


Secondary Outcome Measures :
  1. Presence of any genetic mutations [ Time Frame: one day ]
    Sequencing of a panel of colorectal cancer genes: the 45 genes will be sequenced frequently mutated in colorectal cancer, through the protocols established in the center Executor: APC, TP53, FBXW7, SOX9, ATM, SMAD4, KRAS, PIK3CA, AMER1, FAT4, ARID1A, BRAF, NRAS, CTNNB1, TCF7L2, ERBB2, MET, EGFR, HRAS, SETD2, DLC1, CDKN2A, PTEN, ARID2, FAT1, POLE, POLD1, NOTCH1, BRCA2, LRP1B, KMT2C, KMT2D, DAPK1, CSMD1, MUC16, ADAMTS15, SYNE1, PCLO, ZFHX4, RYR3, RYR2, RELN, IRS2, GNAS, DMBT1.

  2. Number of genome copies using SNP-arrays [ Time Frame: one day ]
    Number of copies using SNP-arrays.


Biospecimen Retention:   Samples With DNA
Paraffin blocks of colorectal polyps


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients > 18 years old who undergo a colonoscopy for any reason
Criteria

Inclusion criteria:

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

Exclusion criteria are:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748667


Contacts
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Contact: Ignasi Puig, MD, PhD 0034938742112 ext 3840 ignasipuig@gmail.com
Contact: Anna Cano, Data manager 0034938742112 ext 3840 digestendos@gmail.com

Locations
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United States, California
San Francisco Veterans Affairs Medical Center. University of California Not yet recruiting
San Francisco, California, United States, 94121
Contact       endoresection@me.com   
Principal Investigator: Tonya Kaltenbach         
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact       mcgills@email.unc.edu   
Principal Investigator: Sarah McGill         
Japan
National Cancer Center Not yet recruiting
Tokyo, Japan, 104-0045
Contact       tasakamo529@gmail.com   
Principal Investigator: Taku Sakamoto         
Spain
Hospital Clínico Universitario Lozano Blesa Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Contact       angel.ferrandez@telefonica.net   
Principal Investigator: Ángel Ferrández         
Hospital Universitari Germans Trias i Pujol (Can Ruti) Not yet recruiting
Badalona, Cataluña, Spain, 08916
Contact       hugoikuo@gmail.com   
Principal Investigator: Hugo Uchima         
Hospital Clínic de Barcelona Not yet recruiting
Barcelona, Cataluña, Spain, 08036
Contact       MPELLISE@clinic.cat   
Principal Investigator: Maria Pellisé         
Sub-Investigator: Miriam Cuatrecasas         
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Not yet recruiting
Barcelona, Cataluña, Spain, 08036
Contact       JCAMPS@clinic.cat   
Sub-Investigator: Jordi Camps         
Althaia. Xarxa Assistencial Universitària de Manresa Not yet recruiting
Manresa, Cataluña, Spain, 08243
Contact       orosinol@althaia.cat   
Sub-Investigator: Òria Rosiñol         
Hospital Universitario y Politécnico de La Fe Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46009
Contact       mbustamantebalen@gmail.com   
Principal Investigator: Marco Bustamante         
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Contact       edualbeniz@hotmail.com   
Principal Investigator: Eduardo Albéniz         
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact       enrodesan@gmail.com   
Principal Investigator: Enrique Rodríguez         
Hospital 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Contact       josecarlos.marin@salud.madrid.org   
Principal Investigator: José Carlos Marín         
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Hospital Universitario La Fe
Hospital Clínico Universitario Lozano Blesa
University of North Carolina, Chapel Hill
Hospital Clinic of Barcelona
National Cancer Center, Japan
Germans Trias i Pujol Hospital
Hospital Universitario 12 de Octubre
Complejo Hospitalario de Navarra
Hospital Universitario Ramon y Cajal
San Francisco Veterans Affairs Medical Center
Investigators
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Principal Investigator: Ignasi Puig, MD, PhD Althaia Xarxa Assistencial Universitària de Manresa

Publications:

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Responsible Party: Ignasi Puig del Castillo, Gastroenterology consultant, MD, PhD, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier: NCT03748667     History of Changes
Other Study ID Numbers: CEIC 18/53
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignasi Puig del Castillo, Althaia Xarxa Assistencial Universitària de Manresa:
Endoscopy
Colonoscopy
Invasive pattern
Polypectomy
NBI
BLI
Deep submucosal invasion
JNET
Kudo pit pattern
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases