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Trial record 23 of 5215 for:    colon cancer

Novel Biophotonics Methodology for Colon Cancer Screening (BRP)

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ClinicalTrials.gov Identifier: NCT04031963
Recruitment Status : Completed
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborators:
Northwestern University
University of Chicago
Indiana University
Stanford University
Information provided by (Responsible Party):
NorthShore University HealthSystem

Brief Summary:
This is a proposal to establish a Bioengineering Research Partnership (BRP). The major objective of the BRP is to refine and provide comprehensive, definitive multi-center validation of these novel methodologies for colorectal cancer (CRC) screening, thus providing a quantum leap in population screening.

Condition or disease
Colon Cancer

Detailed Description:

Background and Significance highlights the impracticality to provide total colonic evaluation for the entire population. Risk-stratification via exploitation of the "field effect" is an attractive approach. However, all existing methodologies (e.g FOBT, fecal DNA, flexible sigmoidoscopy) are clearly suboptimal underscoring the need for novel tools for identifying the field effect.

1) We have developed ELF/LEBS for depth-selective (from ~30 to hundreds of microns) spectroscopic assessment of living tissue. 2) We tested these novel techniques in two animal models of CRC (the AOM-treated rat and MIN-mouse) and in human subjects (n=190). We demonstrated that ELF/LEBS has the potential to detect precancerous changes in the colon at a time point that precedes the formation of adenomas and other histological/molecular markers of CRC. 3) We demonstrated that rectal ELF/LEBS can detect field effect alterations in histologically normal rectal tissue changes due to the presence of adenomas anywhere in the colon. In our pilot studies, the diagnostic accuracy of rectal ELF/LEBS far exceeded any other currently known markers of CRC. Therefore, assaying ELF/LEBS in the rectum has the potential to provide accurate risk-stratification for colon carcinogenesis without the need for bowel preparation and colonoscopy. 4) We have developed prototypes of ELF and LEBS fiber-optics probes for in vivo use.


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Study Type : Observational
Actual Enrollment : 857 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Novel Biophotonics Methodology for Colon Cancer Screening
Actual Study Start Date : September 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Group/Cohort
No treatment
Those with colon cancer and with adenomatous polyp and those without a previously mentioned condition.



Primary Outcome Measures :
  1. Early cancer changes in the colon [ Time Frame: Visit 1, screening colonoscopy ]
    ELF/LEBS probe used to obtain spectroscopy readings from rectal tissue



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients going under colonoscopy or sigmoidoscopy procedure.
Criteria

Inclusion Criteria:

  • Subject is 18 years old or older and is having a colonoscopy procedure.

Exclusion Criteria:

  • Concurrent usage of anticoagulation or blood thinner medication within the last 7 days that would preclude Hx of Inflammatory Bowel Disease/Colitis/Chemotherapy.

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): NCT04031963


Locations
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United States, Illinois
NorthShore Univeristy HealthSystems
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
Northwestern University
University of Chicago
Indiana University
Stanford University
Investigators
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Principal Investigator: Hemant Roy, MD NorthShore University HealthSystem

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Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT04031963     History of Changes
Other Study ID Numbers: R01CA128641 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by NorthShore University HealthSystem:
Novel Biophotonic Methodology for Colon Cancer Screening.
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases