NCT02782793

Brief Summary

A prospective outcomes study in patients referred for endoscopic mucosal resection of complex colon polyps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

4 active sites

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

August 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2.4 years

First QC Date

May 12, 2016

Last Update Submit

June 15, 2017

Conditions

Colon Polyps

Keywords

EndoscopicMucosalResection

Outcome Measures

Primary Outcomes (1)

  • Endoscopic and clinical factors which predict failure of resection of large colon polyps

    A systematic, prospective collection of data from a large cohorts of patients referred for colon EMR will provide useful data in effort to improve overall patient outcomes.

    5 year follow up

Secondary Outcomes (2)

  • Efficacy (%) of Endoscopic resection for large colon polyps

    5 year follow up

  • Factors which predict recurrence of adenoma after large polyp resection

    5 year follow up

Study Arms (1)

Patient's with complex colon polyps

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal ResectionPROCEDURE
Patient's with complex colon polyps

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Formation of a multi-site prospective database of patients refereed for endoscopic mucosal resection for a complex colon polyp(s).

You may qualify if:

  • All patients referred to each of the participating tertiary care centers for endoscopic mucosal resection (EMR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of Colorado, Denver

Denver, Colorado, 80202, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endoscopy

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 25, 2016

Study Start

August 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)