Partial Wave Spectroscopic Detection of Colon Cancer Risk (Brushings)

May 20, 2016 updated by: University of Chicago
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago, DCAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are scheduled to undergo a standard of care flexible sigmoidoscopy or a colonoscopy and have a history of UC.

Description

Inclusion Criteria:

  • Patient must be 18 years old or older.
  • Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy.
  • Patient has not received chemotherapy.
  • History of ulcerative colitis.

Exclusion Criteria:

  • Patient is unable to give informed consent..
  • Patient has received chemo or radiation therapy within the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Study Group
All subjects who are undergoing a standard of care colonoscopy for flexible sigmoidoscopy and have a history of UC and agree to participate will be in the main study group.
Procedure: PWS Testing
Partial wave spectroscopy (PWS)has been developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study samples of rectal mucosa (the moist lining of the rectum) using PWS.
Time Frame: 1 year
Samples will be collected and then shipped to Northwestern University for analysis using PWS. This is to assess accuracy of detecting the risk for colon cancer.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 26, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-066-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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