Colonic PolypNCT02970760
Computer Assisted Measurement of Colorectal Polyps
An observational study of Colonic Polyp, run by Technical University of Munich at 1 site in Germany.
Trial summary
Adenomas are polyps of the colorectum that have the potential to develop into colon cancer. However, some adenomas never become malignant tumors, or if so, progression from adenoma into cancer takes a long time. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Polyp
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Apr 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colonoscopy
Who may be able to join
- indication for colonoscopy
- patients >= 18 years
Who cannot join
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
Peter Klare, MD, + 49 89 4140 ext. 9340, peter.klare@tum.de
Stefan von Delius, Prof., + 49 89 4140 ext. 5973, stefan_ruckert@yahoo.de
About this study
Adenomas are polyps of the colorectum that have the potential to develop into colon cancer. However, some adenomas never become malignant tumors, or if so, progression from adenoma into cancer takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.
The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps. The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be inserted into the colon through a small working channel of the endoscope. Information on the actual adenoma size is crucial as surveillance recommendations depend on the size of the resected polyps. Moreover current guidelines contain the possibilities to disregard hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their benign dignity. However, there is increasing evidence that large human bias effects exist in estimating the size of polypoid lesions. For example, it has been shown that endoscopists exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In consequence the human bias problem might lead to wrong adenoma surveillance decisions.
There is no doubt that technical devices are needed which can support endoscopists in finding the right declaration of polyp sizes. The aim of the current project is to create a computer program that is able to automatically measure polyp sizes during colonoscopy.
- Conditions
- Colonic Polyp
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp size as assessed by the computer program
The predicted polyp size (made by the computer program) will be assessed; the size will be compared with the actual polyp size (as assessed by endoscopist = gold standard). Participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970760
- Sponsor's protocol ID
- CAMP
- Status last verified
- Nov 2016
- First submitted
- 18 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Measurement of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT02970760
- Acronym / sponsor ID
- CAMP
- Conditions
- Colonic Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 22 Nov 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.
Adenomas are polyps of the colorectum that have the potential to develop into colon cancer. However, some adenomas never become malignant tumors, or if so, progression from adenoma into cancer takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer.
The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps. The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be inserted into the colon through a small working channel of the endoscope. Information on the actual adenoma size is crucial as surveillance recommendations depend on the size of the resected polyps. Moreover current guidelines contain the possibilities to disregard hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their benign dignity. However, there is increasing evidence that large human bias effects exist in estimating the size of polypoid lesions. For example, it has been shown that endoscopists exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In consequence the human bias problem might lead to wrong adenoma surveillance decisions.
There is no doubt that technical devices are needed which can support endoscopists in finding the right declaration of polyp sizes. The aim of the current project is to create a computer program that is able to automatically measure polyp sizes during colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colonoscopy
Key inclusion criteria (2 listed)
- indication for colonoscopy
- patients >= 18 years
Key exclusion criteria (5 listed)
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Polyp size as assessed by the computer program
Time frame: up to 2 weeks
The predicted polyp size (made by the computer program) will be assessed; the size will be compared with the actual polyp size (as assessed by endoscopist = gold standard). Participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No
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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.
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 Colonic Polyp, run by Technical University of Munich at 1 site in Germany.
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 2 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 22 Nov 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 Germany. 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 Peter Klare, MD (+ 49 89 4140 ext. 9340, peter.klare@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp size as assessed by the computer program (time frame: up to 2 weeks). 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 22 Nov 2016.