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Incidence of colorectal lesions in first degree relatives of patients with serrated polyposis syndrome.


- candidate number10980
- NTR NumberNTR3252
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2012
- Secondary IDs08/144 METC AMC
- Public TitleIncidence of colorectal lesions in first degree relatives of patients with serrated polyposis syndrome.
- Scientific TitleIncidence of colorectal lesions in first degree relatives of patients with serrated polyposis syndrome.
- ACRONYMPROTECT
- hypothesisTo prospectively study the incidence of polyps and CRC in first degree relatives of patients with serrated polyposis syndrome.
- Healt Condition(s) or Problem(s) studiedHyperplastic polyposis syndrome, Colorectal cancer, Serrated polyposis syndrome, Sessile serrated adenoma
- Inclusion criteriaFirst degree relatives (>35 years of age or 5 years younger than the lowest incidence age) of SPS patients under surveillance at the endoscopy department.
- Exclusion criteria1. Individuals who have undergone a colonoscopy in the past three years;
2. Indivuals who have undergone a colectomy;
3. Severe co-morbidity;
4. Incomlpete colonoscopy;
5. Poor bowel preparation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2008
- planned closingdate1-apr-2012
- Target number of participants79
- InterventionsAll eligble FDRs are invited to undergo a standard white light screening colonoscopy.
- Primary outcomeThe incidence of CRC, adenoma detection rate (ADR) and presence of multiple (>2) proximal serrated polyps (HPs or SSAs).
- Secondary outcomeThe incidence of complications.
- TimepointsInclusion: December 2008 - march 2012.
Data analysis: March 2012.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Y. Hazewinkel
- CONTACT for SCIENTIFIC QUERIESMd PhD E. Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gastroenterology
- PublicationsN/A
- Brief summarySerrated polyposis syndrome (SPS) is characterized by the presence of multiple colorectal hyperplastic polyps (HPs) and sessile serrated adenomas (SSAs) and is associated with an increased colorectal cancer (CRC) risk. First degree relatives (FDRs) of SPS patients are also believed to have an increased risk for both CRC and SPS, but only scarce retrospective data are available. Prospective evaluation of the magnitude of these risks in FDRs is necessary to determine whether screening colonoscopies are indicated in these persons. The aim of this study is a prospective assessment of the prevalence, distribution and type of neoplasia in FDRs of SPS patients.

We will invite all FDRs > 35 years of age or 5 yrs younger than the index case for a screening colonoscopy. FDRs who had already undergone a colonoscopy in the last 3 years and FDRs with a medical history of CRC will be excluded. All responders undergo a standard white light colonoscopy, either in an academic or local hospital. All polyps are removed or biopsied if very small. Primary outcomes are the incidence of CRC, adenoma detection rate (ADR) and presence of multiple (>2) proximal serrated polyps (HPs or SSAs). In order to assess whether screening colonoscopies are justified in FDRs of SPS patients, we compare the ADR in this cohort with previously reported ADRs in subjects of the same age fulfilling the criteria of familial CRC.
- Main changes (audit trail)
- RECORD19-jan-2012 - 31-jan-2012


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