Accuracy for Predicting Deep Submucosal Invasion (NBIBLI)
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|ClinicalTrials.gov Identifier: NCT03748667|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : August 2, 2021
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Colorectal Polyp||Diagnostic Test: White light endoscopy (WLE) Diagnostic Test: NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)|
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).
|Study Type :||Observational|
|Estimated Enrollment :||1158 participants|
|Official Title:||Diagnostic Accuracy of Deep Submucosal Invasion: White Light Endoscopy vs Invasive Pattern Based on NBI/BLI ± Chromoendoscopy|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- 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.
- 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.
- 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.
- 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.
- Number of genome copies using SNP-arrays [ Time Frame: one day ]Number of copies using SNP-arrays.
Biospecimen Retention: Samples With DNA
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
|Contact: Ignasi Puig, MD, PhD||0034938742112 ext firstname.lastname@example.org|
|Contact: Anna Cano, Data manager||0034938742112 ext email@example.com|
|United States, California|
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|San Francisco, California, United States, 94121|
|Principal Investigator: Tonya Kaltenbach|
|United States, North Carolina|
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|Chapel Hill, North Carolina, United States, 27599|
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|Principal Investigator: Taku Sakamoto|
|Hospital Clínico Universitario Lozano Blesa||Not yet recruiting|
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|Principal Investigator: Ángel Ferrández|
|Hospital Universitari Germans Trias i Pujol (Can Ruti)||Recruiting|
|Badalona, Cataluña, Spain, 08916|
|Principal Investigator: Hugo Uchima|
|Hospital Clínic de Barcelona||Recruiting|
|Barcelona, Cataluña, Spain, 08036|
|Principal Investigator: Maria Pellisé|
|Sub-Investigator: Miriam Cuatrecasas|
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|Barcelona, Cataluña, Spain, 08036|
|Sub-Investigator: Jordi Camps|
|Althaia. Xarxa Assistencial Universitària de Manresa||Not yet recruiting|
|Manresa, Cataluña, Spain, 08243|
|Sub-Investigator: Òria Rosiñol|
|Hospital Universitario y Politécnico de La Fe||Not yet recruiting|
|Valencia, Comunidad Valenciana, Spain, 46009|
|Principal Investigator: Marco Bustamante|
|Hospital Clinico Universitario Virgen de la Arrixaca||Not yet recruiting|
|El Palmar, Murcia, Spain, 30120|
|Principal Investigator: Akiko Ono|
|Hospital Comarcal de Alcañiz||Recruiting|
|Alcañiz, Teruel, Spain, 44600|
|Principal Investigator: Marina Solano|
|Centro Médico Teknon||Recruiting|
|Barcelona, Spain, 08022|
|Principal Investigator: Hugo Uchima|
|Hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Principal Investigator: Enrique Rodríguez|
|Hospital 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Principal Investigator: José Carlos Marín|
|Principal Investigator:||Ignasi Puig, MD, PhD||Althaia Xarxa Assistencial Universitària de Manresa|