Colon PolypsNCT02332772
Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions
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 performance of colonoscopic resection of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection of colon polyps and flat lesions and identity areas for improvement. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- 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
- Apr 2015to Apr 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing endoscopy at MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- 1. All Patients who have been referred for endoscopic resection of large polyps (>1 cm) and flat lesions.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Gottumukkala S. Raju, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
With this study, the investigators plan to review the performance of colonoscopic resection of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection of colon polyps and flat 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 (Endoscopy Clinic database) and electronic medical record system (Clinic Station) to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 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 Polyps, Large polyps, Flat lesions, Endoscopy, Colonoscopic resection, Colonoscopy, Data review, Data collection
- 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 collected from endoscopy procedures.
| Study group | Role | What they receive |
|---|---|---|
| Data Collection Endoscopy of Colon Polyps | Data collected from endoscopy reports and electronic medical record system to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 12/31/2025. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions
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 startApr 2015
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (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
- NCT02332772
- Sponsor's protocol ID
- PA14-0866
- Status last verified
- May 2019
- First submitted
- 2 Jan 2015
- Last updated
- 13 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions
- ClinicalTrials.gov ID
- NCT02332772
- Acronym / sponsor ID
- PA14-0866
- Conditions
- Colon Polyps
- Keywords
- Colon Polyps, Large polyps, Flat lesions, Endoscopy, Colonoscopic resection, Colonoscopy, Data review, Data collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (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 performance of colonoscopic resection of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection of colon polyps and flat 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 (Endoscopy Clinic database) and electronic medical record system (Clinic Station) to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 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 |
|---|---|---|
| Data Collection Endoscopy of Colon Polyps | – | Other: Data CollectionData collected from endoscopy reports and electronic medical record system to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 12/31/2025. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing endoscopy at MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (1 listed)
- 1. All Patients who have been referred for endoscopic resection of large polyps (>1 cm) and flat lesions.
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 collected from endoscopy procedures. | Other | Data Collection Endoscopy of Colon Polyps |
Primary outcome
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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. This study is not recruiting at the moment.
Gottumukkala S. Raju, MD contact
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: status not confirmed, as of the sponsor's last update on 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gottumukkala S. Raju, MD (713-563-4377), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions (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 13 May 2019.