NCT03442270

Brief Summary

An observational prospective will be conducted to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

February 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
Last Updated

June 14, 2019

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

February 16, 2018

Last Update Submit

June 12, 2019

Conditions

Healthy Patients Undergoing Screening Colonoscopy

Keywords

Serrated Adenoma, Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Serrated Adenoma

    Prevalence of Serrated Adenoma

    March 2018 to October 2018

Interventions

No InterventionOTHER

This is an observational study, so standard of care will be followed.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 50 years or older undergoing first-time colonoscopy screening

You may qualify if:

  • Males and females

You may not qualify if:

  • First degree relative (patient's parent, sibling or child) diagnosed with colorectal carcinoma at age of 59 or under
  • New onset of iron deficiency anemia (within past 3 months)
  • Abnormal imaging of colon within past 3 months
  • Inadequate visualization reported by endoscopist
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82.

    PMID: 24775268BACKGROUND

Study Design

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

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

March 20, 2018

Primary Completion

November 7, 2018

Study Completion

November 7, 2018

Last Updated

June 14, 2019

Record last verified: 2018-05

Locations

US(1)