Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
1 other identifier
observational
600
1 country
1
Brief Summary
This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 1, 2018
July 1, 2018
4 years
March 28, 2016
July 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
Through study completion, an average of 1 year
Interventions
Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.
Eligibility Criteria
The study population will be obtained in the gastroenterology clinics.
You may qualify if:
- \- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
You may not qualify if:
- age \<50
- personal/family history of colonic neoplasia
- personal history of coagulopathy
- (retrospectively) failure to complete or inadequate colonoscopy
- any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
Radosevich AJ, Mutyal NN, Eshein A, Nguyen TQ, Gould B, Rogers JD, Goldberg MJ, Bianchi LK, Yen EF, Konda V, Rex DK, Van Dam J, Backman V, Roy HK. Rectal Optical Markers for In Vivo Risk Stratification of Premalignant Colorectal Lesions. Clin Cancer Res. 2015 Oct 1;21(19):4347-4355. doi: 10.1158/1078-0432.CCR-15-0136. Epub 2015 May 19.
PMID: 25991816BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
The Quyen Nguyen, Ph.D.
American BioOptics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2016
First Posted
April 6, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
August 1, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
The investigators will assure the confidentiality of all human subjects' data and will adhere to all HIPAA rules by, for example, de-identifying data as appropriate to ensure compliance with human subject confidentiality requirements. The investigators will share research outcomes through conference presentations, and through publications as soon as is feasible after peer review.