Colon PolypsNCT02332785
Prospective Study of Colon Serrated Polyps
An observational study of Colon Polyps, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Polyps
- What is being tested?
- Data Collection
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants undergoing colonoscopy at MD Anderson Cancer Center in Houston, Texas.
Who may be able to join
- 1. All Patients with a serrated polyp (Hyperplastic polyps above sigmoid colon, sessile serrated adenoma, traditional serrated adenoma)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
MD Anderson Health Information Specialist, 877-632-6789
About this study
With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.
Read the detailed description
Our goal is to collect data from our endoscopy reports and electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025.
Specific variable to be reviewed:
- Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
- Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR]).
- Comorbid conditions: cancer and surgical history, medical conditions.
- Colonoscopy procedure: Quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon), cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
- Examination findings: Number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat); optical features and histology of polyps.
- Resection techniques: Biopsy, snare resection, endoscopic mucosal resection, endoscopic submucosal dissection etc.
- Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
- Outcomes of colonoscopy: Complete or incomplete resection, local recurrence, need for surgery, etc.
- Outcome of colonoscopy: Complications (Bleeding and perforation).
- Conditions
- Colon Polyps
- Being tested
- Data Collection
- Keywords
- Colon Serrated Polyps, Serrated polyp, Hyperplastic polyps above sigmoid colon, Sessile serrated adenoma, Traditional serrated adenoma, Colonoscopy, Endoscopy, Data collection, Data review
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Data collection of endoscopy procedure reports of participants with serrated polyps at MD Anderson Cancer Center in Houston, Texas.
| Study group | Role | What they receive |
|---|---|---|
| Composite Data Collection of Endoscopy of Serrated Polyps | Goal is to collect data from endoscopy reports \& electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Review of Colonoscopic Resection of Serrated Colon Polyps
Descriptive tables presented for demographics, polyp counts, colonoscopy experiences, polyp removals and findings. Proportions presented with 95% confidence intervals.
Continuous values such as age and times presented with median, minimum and maximum. Comparisons among patient subgroups made with chi-square tests for categorical data and t-tests or the non-parametric alternative, Wilcoxon tests, to compare continuous measures.
Graphics such as box plots, trellis plots, bar graphs, or stacked bar graphs used to describe distributions overall and among subgroups.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gottumukkala S. Raju, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332785
- Sponsor's protocol ID
- PA14-0879
- Status last verified
- May 2019
- First submitted
- 2 Jan 2015
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Colon Serrated Polyps
- ClinicalTrials.gov ID
- NCT02332785
- Acronym / sponsor ID
- PA14-0879
- Conditions
- Colon Polyps
- Keywords
- Colon Serrated Polyps, Serrated polyp, Hyperplastic polyps above sigmoid colon, Sessile serrated adenoma, Traditional serrated adenoma, Colonoscopy, Endoscopy, Data collection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jan 2015 (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.
With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.
Detailed description
Our goal is to collect data from our endoscopy reports and electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025.
Specific variable to be reviewed:
- Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
- Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR]).
- Comorbid conditions: cancer and surgical history, medical conditions.
- Colonoscopy procedure: Quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon), cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
- Examination findings: Number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat); optical features and histology of polyps.
- Resection techniques: Biopsy, snare resection, endoscopic mucosal resection, endoscopic submucosal dissection etc.
- Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
- Outcomes of colonoscopy: Complete or incomplete resection, local recurrence, need for surgery, etc.
- Outcome of colonoscopy: Complications (Bleeding and perforation).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Composite Data Collection of Endoscopy of Serrated Polyps | – | Other: Data CollectionGoal is to collect data from endoscopy reports \& electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants undergoing colonoscopy at MD Anderson Cancer Center in Houston, Texas.
Key inclusion criteria (1 listed)
- 1. All Patients with a serrated polyp (Hyperplastic polyps above sigmoid colon, sessile serrated adenoma, traditional serrated adenoma)
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Data CollectionData collection of endoscopy procedure reports of participants with serrated polyps at MD Anderson Cancer Center in Houston, Texas. | Other | Composite Data Collection of Endoscopy of Serrated Polyps |
Primary outcome
Data Review of Colonoscopic Resection of Serrated Colon Polyps
Time frame: 1 day
Descriptive tables presented for demographics, polyp counts, colonoscopy experiences, polyp removals and findings. Proportions presented with 95% confidence intervals. Continuous values such as age and times presented with median, minimum and maximum. Comparisons among patient subgroups made with chi-square tests for categorical data and t-tests or the non-parametric alternative, Wilcoxon tests, to compare continuous measures. Graphics such as box plots, trellis plots, bar graphs, or stacked bar graphs used to describe distributions overall and among subgroups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Gottumukkala S. Raju, MD principal investigator
M.D. Anderson Cancer Center
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 Polyps, run by M.D. Anderson Cancer Center 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 1 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: looking for participants now, as of the sponsor's last update on 14 May 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gottumukkala S. Raju, MD (713-563-4377, GSRaju@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Review of Colonoscopic Resection of Serrated Colon Polyps (time frame: 1 day). 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 14 May 2019.