NCT02876133

Brief Summary

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions. Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.

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
987

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

August 18, 2016

Last Update Submit

September 25, 2018

Conditions

Colon CancerColon Sessile Serrated Adenoma/Polyp

Outcome Measures

Primary Outcomes (1)

  • average number of serrated lesions ≥10 mm detected per colonoscopy

    immediate

Secondary Outcomes (7)

  • Serrated class lesions detection rate

    immediate

  • Serrated lesions <10 mm detected per colonoscopy

    immediate

  • SSL detection rate

    immediate

  • Adenoma detection rate

    immediate

  • Adenomas detected per colonoscopy

    immediate

  • +2 more secondary outcomes

Study Arms (2)

Narrow band imaging withdrawal

EXPERIMENTAL

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Device: narrow band imaging withdrawal

white light withdrawal

PLACEBO COMPARATOR

colonoscope withdrawal and mucosal inspection performed under white light imaging

Device: white light withdrawal

Interventions

narrow band imaging withdrawalDEVICE

colonoscope withdrawal and mucosal inspection performed under narrow band imaging

Narrow band imaging withdrawal
white light withdrawalDEVICE

colonoscope withdrawal and mucosal inspection performed under white light imaging

white light withdrawal

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective colonoscopies

You may not qualify if:

  • known polyposis syndromes
  • primary sclerosing cholangitis
  • inflammatory bowel disease
  • personal colorectal cancer history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Beatriz Ângelo

Loures, Portugal

RECRUITING

Centro Hospitalar do Porto

Porto, Portugal

NOT YET RECRUITING

Instituto Português de Oncologia do Porto

Porto, Portugal

NOT YET RECRUITING

Related Publications (1)

  • Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19.

    PMID: 22710576BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsPolyps

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre O Ferreira, MD

    Hospital Beatriz Ângelo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre O Ferreira, MD

CONTACT

alex.gastrohep@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(3)