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Colorectal Polyp Resection Adequacy

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ClinicalTrials.gov Identifier: NCT02217085
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.

Condition or disease
Polyp Resection Adequacy

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
Study Start Date : May 2014
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins). [ Time Frame: Between 3-6 months ]
    Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.


Biospecimen Retention:   Samples With DNA
Polyp margins will be biopsied and retained.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for colorectal adenomatous polyps.
Criteria

Inclusion Criteria:

  • Age 40-80

Exclusion Criteria:

  • Coagulopathy (international normalized ratio >2)
  • Inflammatory bowel disease or other active colitides
  • Polyps of index colonoscopy that were felt not to be completely resected or pedunculated
  • Familial adenomatous polyposis or hereditary polyposis
  • Potential hereditary cancer syndrome (Lynch Syndrome)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217085


Contacts
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Contact: Sarah Goldberg, BA 312-563-3907 sarah_a_goldberg@rush.edu
Contact: GI Research 312-942-3466 gi_research@rush.edu

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Josh E Melson, MD, MPH         
Sponsors and Collaborators
Rush University Medical Center
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02217085    
Other Study ID Numbers: RSA-RTSC 2014
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
Colorectal Cancer Screening
Colon Cancer Screening
Polyps
Colonoscopy
Additional relevant MeSH terms:
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Polyps
Pathological Conditions, Anatomical