Clinical trial NCT04031963: Novel Biophotonics Methodology for Colon Cancer Screening
Official title: Novel Biophotonics Methodology for Colon Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Novel Biophotonic Methodology for Colon Cancer Screening.
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: University of Chicago
name: Indiana University
name: Stanford University
First posted: 2019-07-25
Enrollment: 857
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients going under colonoscopy or sigmoidoscopy procedure.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Early cancer changes in the colon
timeFrame: Visit 1, screening colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore Univeristy HealthSystems
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Hemant Roy, MD
role: PRINCIPAL_INVESTIGATOR
References: