Ulcerative ColitisBrushingsNCT01095432
Partial Wave Spectroscopic Detection of Colon Cancer Risk
An observational study of Ulcerative Colitis and Colon Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Colon Cancer
- What is being tested?
- PWS Testing
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are scheduled to undergo a standard of care flexible sigmoidoscopy or a colonoscopy and have a history of UC.
Who may be able to join
- Patient must be 18 years old or older.
- Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy.
- Patient has not received chemotherapy.
- History of ulcerative colitis.
Who cannot join
- Patient is unable to give informed consent..
- Patient has received chemo or radiation therapy within the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago, DCAM
Chicago, Illinois, 60637
About this study
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).
Read the detailed description
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.
- Conditions
- Ulcerative Colitis, Colon Cancer
- Being tested
- PWS Testing
- Keywords
- Colonoscopy, Flexible Sigmoidoscopy
- Medical subject headings
- Colitis, Ulcerative, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PWS TestingProcedure or surgery
Partial wave spectroscopy (PWS)has been developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer.
| Study group | Role | What they receive |
|---|---|---|
| Main Study Group | All subjects who are undergoing a standard of care colonoscopy for flexible sigmoidoscopy and have a history of UC and agree to participate will be in the main study group. Receives: Procedure: PWS Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study samples of rectal mucosa (the moist lining of the rectum) using PWS.
Samples will be collected and then shipped to Northwestern University for analysis using PWS. This is to assess accuracy of detecting the risk for colon cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- David T Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095432
- Sponsor's protocol ID
- 10-066-B
- Acronym
- Brushings
- Status last verified
- May 2016
- First submitted
- 24 Mar 2010
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Wave Spectroscopic Detection of Colon Cancer Risk
- ClinicalTrials.gov ID
- NCT01095432
- Acronym / sponsor ID
- Brushings / 10-066-B
- Conditions
- Ulcerative Colitis, Colon Cancer
- Keywords
- Colonoscopy, Flexible Sigmoidoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Mar 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Mar 2010 (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.
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS) in patients who will undergo a standard of care colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC).
Detailed description
The purpose of this study is to study samples of rectal mucosa (the moist lining of the rectum) using a new light scattering technology, called partial wave spectroscopy (PWS)in patients who will undergo a colonoscopy or a flexible sigmoidoscopy and have a history of ulcerative colitis (UC). PWS has been recently developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. We believe that the PWS test will more accurately detect the risk of colon cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Study Group | – | Procedure: PWS TestingAll subjects who are undergoing a standard of care colonoscopy for flexible sigmoidoscopy and have a history of UC and agree to participate will be in the main study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled to undergo a standard of care flexible sigmoidoscopy or a colonoscopy and have a history of UC.
Key inclusion criteria (4 listed)
- Patient must be 18 years old or older.
- Patient is already scheduled for a standard of care colonoscopy or flexible sigmoidoscopy.
- Patient has not received chemotherapy.
- History of ulcerative colitis.
Key exclusion criteria (2 listed)
- Patient is unable to give informed consent..
- Patient has received chemo or radiation therapy within the past 3 months.
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 |
|---|---|---|
| PWS TestingPartial wave spectroscopy (PWS)has been developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer. | Procedure or surgery | Main Study Group |
Primary outcome
Study samples of rectal mucosa (the moist lining of the rectum) using PWS.
Time frame: 1 year
Samples will be collected and then shipped to Northwestern University for analysis using PWS. This is to assess accuracy of detecting the risk for colon cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
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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.
David T Rubin, MD principal investigator
University of Chicago
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 Ulcerative Colitis and Colon Cancer, run by University of Chicago 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study samples of rectal mucosa (the moist lining of the rectum) using PWS. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2016.