Serrated Polyposis SyndromeNCT03450889
Personalized Surveillance Protocol for Serrated Polyposis Syndrome
An observational study of Serrated Polyposis Syndrome and Colorectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
Serrated polyposis syndrome (SPS) is a condition characterized by the presence of multiple serrated polyps (SPs) spread throughout the colorectum and is associated with an increased risk of colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serrated Polyposis Syndrome, Colorectal Cancer
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 319 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 13 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated at one of the participating centres during the study will be eligible for this study if they fulfill the inclusion criteria. Patients will only be included in the final analyses if they underwent at least one protocolled surveillance coloscopy after complete clearing.
Who may be able to join
- Patients with SPS WHO 1 criterion (cumulative ≥ 5 histologically diagnosed SPs proximal to the sigmoid colon, of which 2 ≥ 10mm in diameter) and/or WHO 3 criterion (cumulative ≥ 20 SPs spread throughout the colon, at least 3 of the SPs will have to be situated proximal to the sigmoid colon).
- Age 18 years or older
Who cannot join
- - Germline mutation for hereditary colorectal cancer syndrome (e.g. familial adenomatous polyposis, Lynch syndrome. Not including heterozygous MUTYH mutation)
- Inflammatory bowel disease
- Proctocolectomy
- History of radiotherapy in abdominal region
About this study
Official title: Effectiveness of a Personalized Endoscopic Surveillance Protocol for Patients With Serrated Polyposis Syndrome
Serrated polyposis syndrome (SPS) is a condition characterized by the presence of multiple serrated polyps (SPs) spread throughout the colorectum and is associated with an increased risk of colorectal cancer (CRC). SPS is defined by the World Health Organization (WHO) as the presence of at least 5 SPs proximal to the sigmoid colon, of which 2 ≥10 mm in size (WHO criterion 1), the presence of at least 1 SP proximal to the sigmoid and a first degree relative with SPS (WHO criterion 2), or more than 20 SPs spread throughout the colon (WHO-criterion-3). In practice only WHO 1 and WHO 3 criteria are used.
The condition seems rather common and more prevalent than other polyposis syndromes such as familial adenomatous polyposis (FAP) (1:13.000).
Read more
Several retrospective studies have shown that patients with SPS have an increased risk of developing CRC during endoscopic surveillance. Close endoscopic surveillance to prevent malignant progression of polyps has therefore been advised by several expert groups. However, due to a shortage of prospective data the optimal treatment and surveillance approach is largely unknown.
The current study aims to prospectively evaluate the effectiveness and feasibility of a personalized surveillance protocol for patients with SPS to prevent CRC that is being used in several Dutch and Spanish hospitals. Furthermore, the polyp burden, colonoscopy complication risk and rate of conversion from endoscopic surveillance to colorectal surgery will be examined.
For this purpose, all eligible SPS patients are prospectively enrolled 2013 onwards, and surveyed according to the study protocol. Based on the amount and characteristics of the polyps encountered during surveillance colonoscopy, the next colonoscopy will be scheduled after either 1 year or 2 years.
Patients will undergo surveillance after 1 year in case of:
- Advanced adenoma (≥ 10 mm and/or high-grade dysplasia and/or 25% villous component)
- Serrated polyp ≥ 10mm and/or SP containing dysplasia
- Cumulative ≥5 sessile serrated polyps (SSPs) (irrespective of size), adenomas (irrespective of size) and/or hyperplastic polyps (HPs) ≥5mm
- Surgery needed during previous (clearing or surveillance) endoscopy
Patients will undergo surveillance after 2 years in case none of above is reached
Read the detailed description
This study has an international multi-centre prospective cohort design. The study will be directed by the Academic Medical Centre (AMC), Amsterdam, the Netherlands.
Population base All patients treated at one of the participating centres will be eligible for this study.
Protocol violations Incomplete endoscopic excision of polyps without proper re-colonoscopy Prolonged interval within surveillance colonoscopies (Exceeding protocol with >1 year)
Sample size calculation No sample size calculation is performed, because of the observational design of this study. All eligible patients will be included, unless an exclusion criterion is met. The envisioned number of patients to be included is around 500.
Institutional review board This study is conducted in accordance with the research code of our Institutional Review Board (IRB) on human experimentation as well as in agreement with the Helsinki Declaration. The IRB decided that the study did not apply to the requirements of the Medical Research Involving Human Subjects Act (WMO), as data were collected during routine care and no additional patient interventions will be undertaken. Therefore also no informed consent is needed for this study. The study protocol will be registered on a publicly accessible website register.
- Conditions
- Serrated Polyposis Syndrome, Colorectal Cancer
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Patients will undergo surveillance colonoscopies, with intervals of 1 or 2 years depending on the amount and type of polyps resected during last colonoscopy.
In case patients underwent subtotal colectomy, the term 'colonoscopy' should be replaced with 'sigmoidoscopy'.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | This study uses only one arm. All patients in this intervention arm will be surveyed using the aforementioned study protocol, which means patients will undergo a colonoscopy (or sigmoidoscopy in patients with previous subtotal colectomy) with surveillance intervals of either 1 or 2 years, depending on the amount and type of polyps resected during previous surveillance. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of colorectal cancer during protocolled endoscopic surveillance
Incidence of colorectal cancer after complete clearing of all relevant polyps, during protocolled surveillance phase.
Measured: Up to five years
Secondary outcomes (5)
Incidence of advanced neoplasia during protocolled surveillance phase
Advanced neoplasia is defined as: (tubulo)villous adenomas, adenomas with high-grade dysplasia or diameter of at least 10mm; serrated polyp with dysplasia, traditional serrated adenomas or serrated polyps with a diameter of at least 10mm.
CRC is not included in this definition, since CRC is the primary outcome measure in this study.
Measured: Up to five years
Incidence of non-advanced relevant neoplasia during protocolled surveillance phase
Non-advanced relevant neoplasia is defined as tubular adenomas <10mm, sessile serrated lesions <10mm, hyperplastic polyps of 5-9mm.
Measured: Up to five years
the ratio of annual and biennial surveillance advise
Patients will undergo surveillance colonoscopies with intervals of 1 or 2 years. This outcome measure expresses the relative frequency of these surveillance intervals.
Measured: Up to five years
Incidence of conversion to preventive colorectal surgery
How often is preventive colorectal surgery needed during surveillance, for example because of unresectable polyps. This does not include colorectal surgery due to colorectal cancer.
Measured: Up to five years
Incidence of post-colonoscopy complications
Incidence of complications after colonoscopy (this does not include complications that are effectively solved during the procedure). Severity expressed using Clavien Dindo classification.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Jan 2013
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serrated Polyposis SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Evelien Dekker, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450889
- Sponsor's protocol ID
- CA659011
- Status last verified
- Apr 2019
- First submitted
- 19 Feb 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Personalized Endoscopic Surveillance Protocol for Patients With Serrated Polyposis Syndrome
- ClinicalTrials.gov ID
- NCT03450889
- Acronym / sponsor ID
- CA659011
- Conditions
- Serrated Polyposis Syndrome, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 1 Mar 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.
Serrated polyposis syndrome (SPS) is a condition characterized by the presence of multiple serrated polyps (SPs) spread throughout the colorectum and is associated with an increased risk of colorectal cancer (CRC). SPS is defined by the World Health Organization (WHO) as the presence of at least 5 SPs proximal to the sigmoid colon, of which 2 ≥10 mm in size (WHO criterion 1), the presence of at least 1 SP proximal to the sigmoid and a first degree relative with SPS (WHO criterion 2), or more than 20 SPs spread throughout the colon (WHO-criterion-3). In practice only WHO 1 and WHO 3 criteria are used.
The condition seems rather common and more prevalent than other polyposis syndromes such as familial adenomatous polyposis (FAP) (1:13.000).
Several retrospective studies have shown that patients with SPS have an increased risk of developing CRC during endoscopic surveillance. Close endoscopic surveillance to prevent malignant progression of polyps has therefore been advised by several expert groups. However, due to a shortage of prospective data the optimal treatment and surveillance approach is largely unknown.
The current study aims to prospectively evaluate the effectiveness and feasibility of a personalized surveillance protocol for patients with SPS to prevent CRC that is being used in several Dutch and Spanish hospitals. Furthermore, the polyp burden, colonoscopy complication risk and rate of conversion from endoscopic surveillance to colorectal surgery will be examined.
For this purpose, all eligible SPS patients are prospectively enrolled 2013 onwards, and surveyed according to the study protocol. Based on the amount and characteristics of the polyps encountered during surveillance colonoscopy, the next colonoscopy will be scheduled after either 1 year or 2 years.
Patients will undergo surveillance after 1 year in case of:
- Advanced adenoma (≥ 10 mm and/or high-grade dysplasia and/or 25% villous component)
- Serrated polyp ≥ 10mm and/or SP containing dysplasia
- Cumulative ≥5 sessile serrated polyps (SSPs) (irrespective of size), adenomas (irrespective of size) and/or hyperplastic polyps (HPs) ≥5mm
- Surgery needed during previous (clearing or surveillance) endoscopy
Patients will undergo surveillance after 2 years in case none of above is reached
Detailed description
This study has an international multi-centre prospective cohort design. The study will be directed by the Academic Medical Centre (AMC), Amsterdam, the Netherlands.
Population base All patients treated at one of the participating centres will be eligible for this study.
Protocol violations Incomplete endoscopic excision of polyps without proper re-colonoscopy Prolonged interval within surveillance colonoscopies (Exceeding protocol with >1 year)
Sample size calculation No sample size calculation is performed, because of the observational design of this study. All eligible patients will be included, unless an exclusion criterion is met. The envisioned number of patients to be included is around 500.
Institutional review board This study is conducted in accordance with the research code of our Institutional Review Board (IRB) on human experimentation as well as in agreement with the Helsinki Declaration. The IRB decided that the study did not apply to the requirements of the Medical Research Involving Human Subjects Act (WMO), as data were collected during routine care and no additional patient interventions will be undertaken. Therefore also no informed consent is needed for this study. The study protocol will be registered on a publicly accessible website register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | – | Procedure: ColonoscopyThis study uses only one arm. All patients in this intervention arm will be surveyed using the aforementioned study protocol, which means patients will undergo a colonoscopy (or sigmoidoscopy in patients with previous subtotal colectomy) with surveillance intervals of either 1 or 2 years, depending on the amount and type of polyps resected during previous surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated at one of the participating centres during the study will be eligible for this study if they fulfill the inclusion criteria. Patients will only be included in the final analyses if they underwent at least one protocolled surveillance coloscopy after complete clearing.
Key inclusion criteria (2 listed)
- Patients with SPS WHO 1 criterion (cumulative ≥ 5 histologically diagnosed SPs proximal to the sigmoid colon, of which 2 ≥ 10mm in diameter) and/or WHO 3 criterion (cumulative ≥ 20 SPs spread throughout the colon, at least 3 of the SPs will have to be situated proximal to the sigmoid colon).
- Age 18 years or older
Key exclusion criteria (4 listed)
- - Germline mutation for hereditary colorectal cancer syndrome (e.g. familial adenomatous polyposis, Lynch syndrome. Not including heterozygous MUTYH mutation)
- Inflammatory bowel disease
- Proctocolectomy
- History of radiotherapy in abdominal region
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 |
|---|---|---|
| ColonoscopyPatients will undergo surveillance colonoscopies, with intervals of 1 or 2 years depending on the amount and type of polyps resected during last colonoscopy. In case patients underwent subtotal colectomy, the term 'colonoscopy' should be replaced with 'sigmoidoscopy'. | Procedure or surgery | Intervention arm |
Primary outcome
Incidence of colorectal cancer during protocolled endoscopic surveillance
Time frame: Up to five years
Incidence of colorectal cancer after complete clearing of all relevant polyps, during protocolled surveillance phase.
5 secondary outcomes
Incidence of advanced neoplasia during protocolled surveillance phase
Time frame: Up to five years
Incidence of non-advanced relevant neoplasia during protocolled surveillance phase
Time frame: Up to five years
the ratio of annual and biennial surveillance advise
Time frame: Up to five years
Incidence of conversion to preventive colorectal surgery
Time frame: Up to five years
Incidence of post-colonoscopy complications
Time frame: Up to five years
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 3 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Serrated Polyposis Syndrome
RecruitingObservational study
Early Detection of Advanced Adenomas and Colorectal Cancer
Colorectal Cancer, Colorectal Neoplasms
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.
Evelien Dekker, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
An observational study of Serrated Polyposis Syndrome and Colorectal Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 4 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 3 Apr 2019. 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?
Incidence of colorectal cancer during protocolled endoscopic surveillance (time frame: Up to five years). 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 3 Apr 2019.