Personalized Surveillance Protocol for Serrated Polyposis Syndrome

NCT03450889 | Completed

• 1 other identifier: CA659011
• Study Type: observational
• Target: 319
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Conditions

Serrated Polyposis Syndrome; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of advanced neoplasia during protocolled surveillance phase

  Up to five years

• Incidence of non-advanced relevant neoplasia during protocolled surveillance phase

  Up to five years

• the ratio of annual and biennial surveillance advise

  Up to five years

• Incidence of conversion to preventive colorectal surgery

  Up to five years

• Incidence of post-colonoscopy complications

  Up to five years

Study Arms (1)

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.

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

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'.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Evelien Dekker, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 1, 2018
• Study Start: January 1, 2013
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04