Colon CancerNCT02730702
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
An observational study of Colon Cancer, run by American BioOptics, LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- LEBS - Low coherence enhanced backscattering
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be obtained in the gastroenterology clinics.
Who may be able to join
- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.
- Conditions
- Colon Cancer
- Being tested
- LEBS - Low coherence enhanced backscattering
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEBS - Low coherence enhanced backscatteringDevice
Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American BioOptics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- The Quyen Nguyen, Ph.D., Principal investigator, American BioOptics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730702
- Sponsor's protocol ID
- ABO 2016-01
- Status last verified
- Jul 2018
- First submitted
- 28 Mar 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25991816
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
- ClinicalTrials.gov ID
- NCT02730702
- Acronym / sponsor ID
- ABO 2016-01
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- American BioOptics, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be obtained in the gastroenterology clinics.
Key inclusion criteria (1 listed)
- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEBS - Low coherence enhanced backscatteringUnprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained. | Device | – |
Primary outcome
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 25991816Radosevich 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Quyen Nguyen, Ph.D. principal investigator
American BioOptics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by American BioOptics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.