ColoRectal CancerNCT03035136
Retrospective Study on Epidemiology of Colorectal Lesions
An observational study of ColoRectal Cancer and Colonic Polyp, run by Lyell McEwin Hospital.
Trial summary
Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ColoRectal Cancer, Colonic Polyp, Colonic Neoplasms
- How many people
- 2,658 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 5 Mar 2018
- How long will I take part?
- 1 Day
- 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: All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.
Who may be able to join
- Colonoscopies performed in Lyell McEwin Hospital between 2010-2016
Who cannot join
- Sigmoidoscopies
About this study
Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.
Read the detailed description
Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.
- Conditions
- ColoRectal Cancer, Colonic Polyp, Colonic Neoplasms
- Keywords
- polyps
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps, Colonic 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 |
|---|---|---|
| Patients with colorectal lesions | Patients with a full colonoscopy that showed either a cancer or a polyp. | |
| Patients without colorectal lesions | Patients with a full colonoscopy that showed no polyps. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Percentage of screening patients with at least one adenomatous lesion found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
Measured: Day 1
Secondary outcomes (2)
SSA/P detection rate
Percentage of screening patients with at least one SSA/P found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
Measured: Day 1
Polyp detection rate
Percentage of screening patients with at least one polyp found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start15 Jan 2017
- Primary completion15 Feb 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal CancerStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,658 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Lyell McEwin Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035136
- Sponsor's protocol ID
- SSA/17/NALHN/3
- Status last verified
- Mar 2018
- First submitted
- 25 Jan 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Epidemiology of Colorectal Lesions
- ClinicalTrials.gov ID
- NCT03035136
- Acronym / sponsor ID
- SSA/17/NALHN/3
- Conditions
- ColoRectal Cancer, Colonic Polyp, Colonic Neoplasms
- Keywords
- polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,658 participants (actual)
- Lead sponsor
- Lyell McEwin HospitalOther government
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 27 Jan 2017 (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.
Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.
Detailed description
Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal lesions | – | –Patients with a full colonoscopy that showed either a cancer or a polyp. |
| Patients without colorectal lesions | – | –Patients with a full colonoscopy that showed no polyps. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.
Key inclusion criteria (1 listed)
- Colonoscopies performed in Lyell McEwin Hospital between 2010-2016
Key exclusion criteria (1 listed)
- Sigmoidoscopies
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: Day 1
Percentage of screening patients with at least one adenomatous lesion found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
2 secondary outcomes
SSA/P detection rate
Time frame: Day 1
Polyp detection rate
Time frame: Day 1
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 7 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ColoRectal Cancer and Colonic Polyp, run by Lyell McEwin Hospital.
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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Adenoma detection rate (time frame: Day 1). 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 7 Mar 2018.