Colon NeoplasmNCT03730441
Correlation Between ADR of Screening and All Colonoscopies
An observational study of Colon Neoplasm, run by Hospital Frydek-Mistek at 1 site in Czechia.
Trial summary
The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colon Neoplasm
- What is being tested?
- Colonoscopy
- Type of treatment
- Medical device
- How many people
- 6,925 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2013to Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people over 50 years of age coming for colonoscopic examination
Who may be able to join
- people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)
Who cannot join
- age under 50 years
- indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.
Read the detailed description
ADR (adenoma detection rate) is generally accepted quality indicator and it is calculated from screening colonoscopies in patients over 50 years of age. For possible gaming with ADR for screening colonoscopies, monitoring of ADR for all colonoscopies is discussed nowadays.The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.
We want to retrospectively assess the quality indicators of all colonoscopies performed from January 2013 to December 2017. We want to calculate ADR for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlation analysis will be performed using Pearson´s correlation coefficient.
- Conditions
- Colon Neoplasm
- Being tested
- Colonoscopy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDevice
Endoscopic examination of large bowel
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between ADR of screening and all colonoscopies (screening, surveillance, diagnostic)
Pearson´s correlation coefficient
Measured: january 2013 - december 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study startJan 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 6,925 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Frydek-Mistek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Mikoviny Kajzrlikova, MD, PhD, Hospital Frydek-Mistek
- Investigators
- Ivana Mikoviny Kajzrlikova, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730441
- Sponsor's protocol ID
- ADR
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ADRs of all endoscopists in our unit for both all and screening colonoscopies
Publications
Mikoviny Kajzrlikova I, Vitek P, Chalupa J, Kuchar J, Platos J, Reha P, Klvana P. Correlation between ADR of screening and all colonoscopies. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021 Nov;165(4):386-389. doi: 10.5507/bp.2020.059. Epub 2020 Dec 16.
PubMed 33325459
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between ADR of Screening and All Colonoscopies
- ClinicalTrials.gov ID
- NCT03730441
- Acronym / sponsor ID
- ADR
- Conditions
- Colon Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,925 participants (actual)
- Lead sponsor
- Hospital Frydek-MistekUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Nov 2018 (actual)
- 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.
The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.
Detailed description
ADR (adenoma detection rate) is generally accepted quality indicator and it is calculated from screening colonoscopies in patients over 50 years of age. For possible gaming with ADR for screening colonoscopies, monitoring of ADR for all colonoscopies is discussed nowadays.The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.
We want to retrospectively assess the quality indicators of all colonoscopies performed from January 2013 to December 2017. We want to calculate ADR for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlation analysis will be performed using Pearson´s correlation coefficient.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people over 50 years of age coming for colonoscopic examination
Key inclusion criteria (1 listed)
- people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)
Key exclusion criteria (2 listed)
- age under 50 years
- indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies
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 |
|---|---|---|
| ColonoscopyEndoscopic examination of large bowel | Device | – |
Primary outcome
correlation between ADR of screening and all colonoscopies (screening, surveillance, diagnostic)
Time frame: january 2013 - december 2017
Pearson´s correlation coefficient
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 5 Nov 2018.
- Derived from this study: PubMed 33325459Mikoviny Kajzrlikova I, Vitek P, Chalupa J, Kuchar J, Platos J, Reha P, Klvana P. Correlation between ADR of screening and all colonoscopies. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021 Nov;165(4):386-389. doi: 10.5507/bp.2020.059. Epub 2020 Dec 16.
- Individual participant dataSharing planned: Undecided. ADRs of all endoscopists in our unit for both all and screening colonoscopies
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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.
Ivana Mikoviny Kajzrlikova principal investigator
Doctor
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 Neoplasm, run by Hospital Frydek-Mistek at 1 site in Czechia.
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 2 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 5 Nov 2018. 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 Czechia. 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 between ADR of screening and all colonoscopies (screening, surveillance, diagnostic) (time frame: january 2013 - december 2017). 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 NCT03730441, which also lists 1 linked publication.
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 5 Nov 2018.