Novel Biophotonics Methodology for Colon Cancer Screening | NCT04031963

Studies
Novel Biophotonics Methodology for Colon Cancer Screening

NCT04031963

Sponsor

Endeavor Health

Status

Completed

Last Update Posted

Jul 25, 2019Actual

Enrollment

857Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009Actual

Primary Completion Date

Feb 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 28, 2014

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Name	Class
Northwestern University	OTHER
University of Chicago	OTHER
Indiana University	OTHER
Stanford University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

857Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment		Those with colon cancer and with adenomatous polyp and those without a previously mentioned condition.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early cancer changes in the colon	ELF/LEBS probe used to obtain spectroscopy readings from rectal tissue	Visit 1, screening colonoscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients going under colonoscopy or sigmoidoscopy procedure.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hemant Roy, MD	Endeavor Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NorthShore Univeristy HealthSystems		Evanston	Illinois	60201	United States

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

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Browse Branches

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