Partial Wave Spectroscopic Detection of Colon Cancer Risk

Ulcerative Colitis Clinical Trial

— Brushings  

Official title:

Partial Wave Spectroscopic Detection of Colon Cancer Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095432
• Other study ID #: 10-066-B
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: May 20, 2016
• Start date: March 2010
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colon Cancer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago, DCAM	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study samples of rectal mucosa (the moist lining of the rectum) using PWS.	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	No