NCT03604237

Brief Summary

This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 19, 2018

Last Update Submit

July 19, 2018

Conditions

Colorectal Neoplasms

Keywords

forceps biopsycolorectal tumors

Outcome Measures

Primary Outcomes (1)

  • pathologic diagnosis

    The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.

    7 days

Study Arms (2)

Targeted forceps biopsy

EXPERIMENTAL

In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation.

Diagnostic Test: Targeted group

Conventional forceps biopsy

NO INTERVENTION

In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors.

Interventions

Targeted groupDIAGNOSTIC_TEST

Forceps biopsy is taken after surface evaluation of the large colorectal tumors.

Targeted forceps biopsy

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with colorectal neoplasms of the size larger than 2 cm

You may not qualify if:

  • Patients who deny the participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2018

First Posted

July 27, 2018

Study Start

September 1, 2017

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

KR(1)