- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031963
Novel Biophotonics Methodology for Colon Cancer Screening (BRP)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Evanston, Illinois, United States, 60201
- NorthShore Univeristy HealthSystems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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No treatment
Those with colon cancer and with adenomatous polyp and those without a previously mentioned condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early cancer changes in the colon
Time Frame: Visit 1, screening colonoscopy
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ELF/LEBS probe used to obtain spectroscopy readings from rectal tissue
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Visit 1, screening colonoscopy
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Collaborators and Investigators
Investigators
- Principal Investigator: Hemant Roy, MD, NorthShore University HealthSystem
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01CA128641 (U.S. NIH Grant/Contract)
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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