Detection Rate of Serrated Adenomas in Screening Colonoscopy | NCT03442270

Studies
Detection Rate of Serrated Adenomas in Screening Colonoscopy

NCT03442270

Sponsor

TriHealth Inc.

Status

Completed

Last Update Posted

Jun 14, 2019Actual

Enrollment

276Actual

Phase

Not provided

Conditions

Healthy Patients Undergoing Screening Colonoscopy

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2018Actual

Primary Completion Date

Nov 7, 2018Actual

Completion Date

Nov 7, 2018Actual

First Submitted Date

Feb 16, 2018

First Submission Date that Met QC Criteria

Feb 16, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2019

Last Update Posted Date

Jun 14, 2019Actual

Name	Class
TriHealth Hatton Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Colonoscopy screening is a preventative measure for colorectal carcinoma (CRC), a highly malignant and dangerous cancer. Extensive research on the adenoma detection rate has provided national standards and quality metrics to help assess competence of endoscopists. Currently, there are no standards established for serrated adenomas. The proposed study would be conducted at Good Samaritan Hospital (GSH) and TriHealth Surgery Center West. This is an observational study and does not involve any patient interventions. However, because patient healthcare data will be collected for research, informed consent will be obtained shortly before the procedure. The main study objective is 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

276Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	This is an observational study, so standard of care will be followed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serrated Adenoma	Prevalence of Serrated Adenoma	March 2018 to October 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients 50 years or older undergoing first-time colonoscopy screening

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital		Cincinnati	Ohio	45220	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24775268	Background	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.