Colorectal Cancer Clinical Trial
Official title:
Effectiveness of a Personalized Endoscopic Surveillance Protocol for Patients With Serrated Polyposis Syndrome
NCT number | NCT03450889 |
Other study ID # | CA659011 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2013 |
Est. completion date | April 13, 2018 |
Verified date | April 2019 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 319 |
Est. completion date | April 13, 2018 |
Est. primary completion date | April 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of colorectal cancer during protocolled endoscopic surveillance | Incidence of colorectal cancer after complete clearing of all relevant polyps, during protocolled surveillance phase. | Up to five years | |
Secondary | 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. |
Up to five years | |
Secondary | 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. | Up to five years | |
Secondary | 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. | Up to five years | |
Secondary | 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. | Up to five years | |
Secondary | 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. | Up to five years |
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