NCT04031963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
857

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
5 years until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

July 28, 2014

Last Update Submit

July 23, 2019

Conditions

Colon Cancer

Keywords

Novel Biophotonic Methodology for Colon Cancer Screening.

Outcome Measures

Primary Outcomes (1)

  • Early cancer changes in the colon

    ELF/LEBS probe used to obtain spectroscopy readings from rectal tissue

    Visit 1, screening colonoscopy

Study Arms (1)

No treatment

Those with colon cancer and with adenomatous polyp and those without a previously mentioned condition.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients going under colonoscopy or sigmoidoscopy procedure.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore Univeristy HealthSystems

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Hemant Roy, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 25, 2019

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

US(1)