The aims of this study are: 1) To prospectively determine the incidence of HPS/polyps and CRC in first-degree relatives of patients with HPS so as to define whether screening of this group is justified.2) To assess the proportion of individuals that…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence, distribution and phenotype (gross morphology, number, size,
shape) of polyps and CRC in first-degree relatives of patients with HPS will be
assessed. Based on these findings an estimation of the risk of developing
polyps/ HPS and CRC in this group can be made so as to define whether screening
of this group is justified. In addition, the proportion of individuals that
complied with the screening programme will be assessed as well as the
proportion of non-compliers. In these two groups, socio-demographic data and
potential predictors of compliance behaviour will be compared with the higher
aim of designing an effective surveillance programme for these individuals.
Secondary outcome
geen
Background summary
Hyperplastic polyposis syndrome (HPS) is a condition in which multiple
hyperplastic polyps (HPs) are spread throughout the colon. Patients with HPS
are at increased risk of developing colorectal cancer (CRC) through a suggested
HP-serrated adenoma (SA)-CRC pathway. First-degree relatives are also believed
to have an increased risk of developing colorectal tumours and are therefore
advised to undergo a screening colonoscopy. However, this advice is thus far
based on retrospective studies and hence not adequately substantiated.
Study objective
The aims of this study are:
1) To prospectively determine the incidence of HPS/polyps and CRC in
first-degree relatives of patients with HPS so as to define whether screening
of this group is justified.
2) To assess the proportion of individuals that complied with the screening
programme as well as the proportion of non-compliers. In these two groups,
socio-demographic data and potential predictors of compliance behaviour will be
compared with the higher aim of designing an effective surveillance programme
for these individuals
Study design
First-degree relatives of patients with HPS that are currently under
surveillance at the Academic Medical Centre will be asked permission to collect
their previous colonoscopy data. If they haven*t yet undergone a screening
colonoscopy, they will be advised to do so, in accordance with current
guidelines, at their local hospital or our centre. To investigate the
perception and motivation of individuals with regard to endoscopic screening, a
combined questionnaire will be given before and after colonoscopy. Furthermore,
tissue biopsies and blood samples will be taken and stored for future genetic
analysis.
Study burden and risks
The endoscopic procedure in this study is according to the standard procedure
for regular patient care. The risk of a diagnostic colonoscopy is minimal (<
1%).
meibergdreef 9
1105 AZ, Amsterdam
NL
meibergdreef 9
1105 AZ, Amsterdam
NL
Listed location countries
Age
Inclusion criteria
First-degree relatives (* 35 years of age or 5 years younger than the lowest incidence age) of patients under surveillance at the Endoscopy Department of the AMC with HPS, defined as:
1) *10 HPs found at colonoscopy, or
2) *5 HPs proximal to the sigmoid colon of which 2 are greater than 10mm in diameter, or
3) Any number of HPs occurring proximal to sigmoid colon in an individual who has a first-degree relative with hyperplastic polyposis
Exclusion criteria
Exclusion criteria are 1) individuals who have undergone a colonoscopy in the past three years 2) individuals who have undergone a colectomy 3) severe co-morbidity and 4) age less than 35 years.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23190.018.08 |