Colorectal CancerNCT00860665
Case Volume and Adenoma Rate During Screening Colonoscopy
An observational study of Colorectal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 12,134 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Mar 2009
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In Germany screening colonoscopy is reimbursed over the age of 55 years. All persons willing to undergo screening colonsocopy without contraindications are asked for consent to be included
Who may be able to join
- all persons willing and able to undergo screening colonoscopy over the age of 55 years
Who cannot join
- any condition not compatible with the definition of screening colonoscopy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Medical University Berlin Campus Virchow
Berlin, State of Berlin, 13353
About this study
Official title: Case Volume and Adenoma Detection Rates During Screening Colonoscopy
Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.
Read the detailed description
21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way
Primary outcome parameter:
- Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)
Secondary outcome parameters:
- Complications and method of assessment (immediate recording versus later questionnaire enquiry)
- Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)
- Quality of pathology reports and histologic outcome of polypectomy
Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, prevention, colonoscopy, screening, quality assessment, colorectal cancer prevention
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| 1 | Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of adenoma detection rate with case volume of endoscopists
Measured: 18 months
Secondary outcomes (1)
Patient acceptance in relation to procedural factors (e.g. sedation)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 12,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Interest group of Berlin private practice gastroenterologists
- Investigators
- Thomas Rösch, MD, Principal investigator, Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860665
- Sponsor's protocol ID
- BECOP-3
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Adler A, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Keining C, Stange G, Wiedenmann B, Gauger U, Altenhofen L, Rosch T. Data quality of the German screening colonoscopy registry. Endoscopy. 2013 Oct;45(10):813-8. doi: 10.1055/s-0033-1344583. Epub 2013 Sep 9.
PubMed 24019130Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
PubMed 22442161Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
PubMed 22056301
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Volume and Adenoma Detection Rates During Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT00860665
- Acronym / sponsor ID
- BECOP-3
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, prevention, colonoscopy, screening, quality assessment, colorectal cancer prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,134 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Interest group of Berlin private practice gastroenterologists
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Mar 2009 (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.
Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.
Detailed description
21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way
Primary outcome parameter:
- Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)
Secondary outcome parameters:
- Complications and method of assessment (immediate recording versus later questionnaire enquiry)
- Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)
- Quality of pathology reports and histologic outcome of polypectomy
Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Observational study on consecutive persons over the age of 55 years presenting for screening colonoscopy |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In Germany screening colonoscopy is reimbursed over the age of 55 years. All persons willing to undergo screening colonsocopy without contraindications are asked for consent to be included
Key inclusion criteria (1 listed)
- all persons willing and able to undergo screening colonoscopy over the age of 55 years
Key exclusion criteria (1 listed)
- any condition not compatible with the definition of screening colonoscopy
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
Correlation of adenoma detection rate with case volume of endoscopists
Time frame: 18 months
1 secondary outcome
Patient acceptance in relation to procedural factors (e.g. sedation)
Time frame: 18 months
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 12 Mar 2009.
- Derived from this study: PubMed 24019130Adler A, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Keining C, Stange G, Wiedenmann B, Gauger U, Altenhofen L, Rosch T. Data quality of the German screening colonoscopy registry. Endoscopy. 2013 Oct;45(10):813-8. doi: 10.1055/s-0033-1344583. Epub 2013 Sep 9.
- Derived from this study: PubMed 22442161Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
- Derived from this study: PubMed 22056301Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
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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.
Thomas Rösch, MD principal investigator
Department of Interdisciplinary Endoscopy, Hamburg University Eppendorf, Germany
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 Colorectal Cancer, run by Charite University, Berlin, Germany 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 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: finished, as of the sponsor's last update on 12 Mar 2009. 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?
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?
Correlation of adenoma detection rate with case volume of endoscopists (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860665, which also lists 3 linked publications.
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 12 Mar 2009.