NCT04032912

Brief Summary

Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 12, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

March 24, 2021

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

July 4, 2019

Last Update Submit

March 20, 2021

Conditions

Polyp of Colon

Keywords

Polyp resectionColorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Examine concordance with the pathology-based surveillance recommendation of two new resect and discard models

    Our aim is to examine and to make a comparison of these models with the currently endorsed resect and discard approach that is based on optical polyp diagnosis and we will also obtain histopathology for all polyps as a reference gold-standard to which all models are compared.

    24 months

Secondary Outcomes (4)

  • Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations

    24 months

  • Re-evaluate classical optical biopsy criteria (NICE and SANO classifications)

    24 months

  • Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis

    24 months

  • Evaluate Polyp-Based Resect and Discard model

    24 months

Interventions

iScanDIAGNOSTIC_TEST

this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.

Also known as: Optivista

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All 45-80 year old patients scheduled for an elective colonoscopy with the potential of a polyp removal will be considered for the study. This includes patients hospitalized that do not require an emergency colonoscopy (defined as colonoscopy in the emergency or intensive care unit or patients with active upper or lower gastrointestinal bleeding). Potential study subjects are approached to participate: 1) during an outpatient clinic; 2) at their arrival at the endoscopy clinic on the day of the colonoscopy; or 3) on the hospital ward (for patients hospitalized).

You may qualify if:

  • Signed informed consent form
  • Age 45 to 80 years
  • Indication for full colonoscopy

You may not qualify if:

  • Known inflammatory bowel disease
  • Active colitis
  • Coagulopathy
  • Familial polyposis syndrome
  • Poor general health defined as an ASA class \> 3
  • Emergency colonoscopies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Taghiakbari M, Pohl H, Djinbachian R, Barkun A, Marques P, Bouin M, Deslandres E, Panzini B, Bouchard S, Weber A, von Renteln D. The location-based resect and discard strategy for diminutive colorectal polyps: a prospective clinical study. Endoscopy. 2022 Apr;54(4):354-363. doi: 10.1055/a-1546-9169. Epub 2021 Aug 26.

    PMID: 34448185DERIVED

MeSH Terms

Conditions

Colonic PolypsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniel von Renteln, MD, PhD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 25, 2019

Study Start

May 12, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

March 24, 2021

Record last verified: 2018-04

Locations

CA(1)