Colon AdenomaDECADENCT02057562
Impact of Diverticular Disease on the Detection of Colon Adenomas
An observational study of Colon Adenoma and Diverticulosis, run by Technical University of Munich at 2 sites in Germany.
Trial summary
Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colon Adenoma, Diverticulosis
- How many people
- 1,000 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2014to Mar 2017
- 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 receiving routine colonoscopy at the both study centers are eligible for participation.
Who may be able to join
- indication for colonoscopy
- age >= 18 years
Who cannot join
- pregnant women
- patients denying written consent
- indication for colonoscopy: familial adenomatous polypose
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: previously known colon polyp/adenoma/carcinoma
- history of colon surgery
- contraindication for resection of polyps
- American Society of Anesthesiologists (ASA) class IV, V or VI
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Rotkreuzklinikum München
München, Deutschland, 80634
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
München, Deutschland, 81677
About this study
Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.
- Conditions
- Colon Adenoma, Diverticulosis
- Keywords
- Adenoma, Diverticular disease, Diverticulosis, Colorectal carcinoma, Polyp
- Medical subject headings
- Diverticulum, Adenoma, Diverticular Diseases, Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine colonoscopy | Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined
Measured: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
Secondary outcomes (2)
Polyp detection rate
a maximum of one day is expected for colonoscopy
Measured: up to one day
Frequency of colon diverticulosis
a maximum of one day is expected for colonoscopy
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Klare, Technical University of Munich
- Investigators
- Peter Klare, MD, Principal investigator, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, GermanyPeter Born, Prof. Dr., Study chair, Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, GermanyStefan von Delius, MD, Study director, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057562
- Sponsor's protocol ID
- DECADE
- Acronym
- DECADE
- Status last verified
- Nov 2016
- First submitted
- 5 Feb 2014
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diverticular Disease on the Detection of Colon Adenomas
- ClinicalTrials.gov ID
- NCT02057562
- Acronym / sponsor ID
- DECADE / DECADE
- Conditions
- Colon Adenoma, Diverticulosis
- Keywords
- Adenoma, Diverticular disease, Diverticulosis, Colorectal carcinoma, Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Feb 2014 (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.
Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine colonoscopy | – | –Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine colonoscopy at the both study centers are eligible for participation.
Key inclusion criteria (2 listed)
- indication for colonoscopy
- age >= 18 years
Key exclusion criteria (8 listed)
- pregnant women
- patients denying written consent
- indication for colonoscopy: familial adenomatous polypose
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: previously known colon polyp/adenoma/carcinoma
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
Adenoma detection rate
Time frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined
2 secondary outcomes
Polyp detection rate
Time frame: up to one day
Frequency of colon diverticulosis
Time frame: up to one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
Peter Klare, MD principal investigator
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Peter Born, Prof. Dr. study chair
Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, Germany
Stefan von Delius, MD study director
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Adenoma and Diverticulosis, run by Technical University of Munich at 2 sites 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 8 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 21 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 2 sites 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?
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?
Adenoma detection rate (time frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 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 21 Nov 2016.