Sessile Serrated AdenomaSERRESHNCT03100552
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
An observational study of Sessile Serrated Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sessile Serrated Adenoma
- What is being tested?
- Endoscopic imaging
- How many people
- 86 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2013to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients referred to a tertiary endoscopic resection practice with any SSP >= 8mm
Who may be able to join
- Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm
Who cannot join
- Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)
Trial locations and contacts
1 site in 1 country.
About this study
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size
Read the detailed description
Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP >= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists
- Conditions
- Sessile Serrated Adenoma
- Being tested
- Endoscopic imaging
- Keywords
- Colonoscopy, Endoscopic resection, Sessile serrated adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic imagingDiagnostic test
Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients referred to a tertiary endoscopic resection practice found to have an SSP >= 8mm. Endoscopic imaging applied to the sessile serrated polyp (SSP) to determine the presence or absence of dysplasia. Receives: Diagnostic Test: Endoscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysplasia
Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology
Measured: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination
Secondary outcomes (1)
Sessile serrated polyp
Determination of a specific polyp as an sessile serrated polyp (SSP)
Measured: at the initial procedure compared with histopathology within 1 week. no ongoing determination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Aug 2013
- Primary completion1 Jan 2017
- Study completion1 Jan 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 Sessile Serrated AdenomaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, FRACP, Principal investigator, WSLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100552
- Sponsor's protocol ID
- 4075
- Acronym
- SERRESH
- Status last verified
- Jun 2023
- First submitted
- 22 Mar 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tate DJ, Jayanna M, Awadie H, Desomer L, Lee R, Heitman SJ, Sidhu M, Goodrick K, Burgess NG, Mahajan H, McLeod D, Bourke MJ. A standardized imaging protocol for the endoscopic prediction of dysplasia within sessile serrated polyps (with video). Gastrointest Endosc. 2018 Jan;87(1):222-231.e2. doi: 10.1016/j.gie.2017.06.031. Epub 2017 Jul 13.
PubMed 28713060
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03100552
- Acronym / sponsor ID
- SERRESH / 4075
- Conditions
- Sessile Serrated Adenoma
- Keywords
- Colonoscopy, Endoscopic resection, Sessile serrated adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 4 Apr 2017 (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.
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size
Detailed description
Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP >= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Endoscopic imagingPatients referred to a tertiary endoscopic resection practice found to have an SSP >= 8mm. Endoscopic imaging applied to the sessile serrated polyp (SSP) to determine the presence or absence of dysplasia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients referred to a tertiary endoscopic resection practice with any SSP >= 8mm
Key inclusion criteria (1 listed)
- Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm
Key exclusion criteria (1 listed)
- Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)
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 |
|---|---|---|
| Endoscopic imagingAnalysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging) | Diagnostic test | Study population |
Primary outcome
Dysplasia
Time frame: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination
Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology
1 secondary outcome
Sessile serrated polyp
Time frame: at the initial procedure compared with histopathology within 1 week. no ongoing determination
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 29 Jun 2023.
- Derived from this study: PubMed 28713060Tate DJ, Jayanna M, Awadie H, Desomer L, Lee R, Heitman SJ, Sidhu M, Goodrick K, Burgess NG, Mahajan H, McLeod D, Bourke MJ. A standardized imaging protocol for the endoscopic prediction of dysplasia within sessile serrated polyps (with video). Gastrointest Endosc. 2018 Jan;87(1):222-231.e2. doi: 10.1016/j.gie.2017.06.031. Epub 2017 Jul 13.
- 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.
Michael Bourke, MBBS, FRACP principal investigator
WSLHD
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 Sessile Serrated Adenoma, run by Western Sydney Local Health District at 1 site in Australia.
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 29 Jun 2023. 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 Australia. 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?
Dysplasia (time frame: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination). 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 NCT03100552, 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 29 Jun 2023.