Accuracy for Predicting Deep Submucosal Invasion

CompletedOBSERVATIONAL
Enrollment

426

Participants

Timeline

Start Date

December 1, 2018

Primary Completion Date

September 28, 2022

Study Completion Date

October 30, 2022

Conditions
Colorectal CancerColorectal Polyp
Interventions
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.

Trial Locations (14)

27599

University of North Carolina, Chapel Hill

28034

Hospital Ramón y Cajal, Madrid

28041

Hospital 12 de Octubre, Madrid

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

44600

Hospital Comarcal de Alcañiz, Alcañiz

46009

Hospital Universitario y Politécnico de La Fe, Valencia

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

94121

San Francisco Veterans Affairs Medical Center. University of California, San Francisco

104-0045

National Cancer Center, Tokyo

08916

Hospital Universitari Germans Trias i Pujol (Can Ruti), Badalona

08036

Hospital Clínic de Barcelona, Barcelona

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

08243

Althaia. Xarxa Assistencial Universitària de Manresa, Manresa

08022

Centro Médico Teknon, Barcelona

All Listed Sponsors
collaborator

Hospital Universitario La Fe

OTHER

collaborator

Hospital Clínico Universitario Lozano Blesa

OTHER

collaborator

University of North Carolina, Chapel Hill

OTHER

collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

National Cancer Center, Japan

OTHER_GOV

collaborator

Germans Trias i Pujol Hospital

OTHER

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Hospital Universitario Ramon y Cajal

OTHER

collaborator

San Francisco Veterans Affairs Medical Center

FED

collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

collaborator

Hospital Comarcal de Alcañiz

UNKNOWN

collaborator

Centro Medico Teknon

OTHER

lead

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

NCT03748667 - Accuracy for Predicting Deep Submucosal Invasion | Biotech Hunter | Biotech Hunter