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Partial Wave Spectroscopic Detection of Colon Cancer Risk (Brushings)

This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01095432
First received: March 24, 2010
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention
Ulcerative Colitis
Colon Cancer
 Procedure: PWS Testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Partial Wave Spectroscopic Detection of Colon Cancer Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Study samples of rectal mucosa (the moist lining of the rectum) using PWS. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

A sample of rectal mucosa will be collected during the subject's standard of care colonoscopy or flexible sigmoidoscopy.


Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095432

Contacts
Contact: Bonnie Surma, RN 773-702-5055 bsurma@medicine.bsd.uchicago.edu
Contact: Todd Miodek, RN, ANP 773-702-5382 tmiodek@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago, DCAM Recruiting
Chicago, Illinois, United States, 60637
Contact: Bonnie Surma, RN     773-702-5055     bsurma@medicine.bsd.uchicago.edu    
Principal Investigator: David T Rubin, MD            
Sponsors and Collaborators
University of Chicago
Northwestern University
Investigators
Principal Investigator: David T Rubin, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01095432     History of Changes
Other Study ID Numbers: 10-066-B
Study First Received: March 24, 2010
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Chicago:
Colonoscopy
Flexible Sigmoidoscopy

Additional relevant MeSH terms:
Colonic Neoplasms
Colitis
Colitis, Ulcerative
Ulcer
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Gastroenteritis
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013