Individuals at high-risk for developing pancreatic cancer: surveillance by endosonography and magnetic resonance imaging: FAMILIAL PANCREATIC CANCER SURVEILLANCE STUDY
- Conditions
- pancreatic cancerpancreatic neoplasia1008362410017991
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
PC prone hereditary syndromes with a cumulative lifetime risk >10% on PC, or
PC prone hereditary syndromes with a unknown cumulative lifetime risk, or <10% for PC, with a familial aggregation of PC (* 2 first-degree relatives with a histologically confirmed PC, or * 3 relatives of any degree with a histologically confirmed PC, one of whom must have been a first-degree relative, or * 2 relatives of any degree, one of whom was at least * 50 years at the time of diagnosis, with a histologically confirmed PC), or
Familial pancreatic cancer (* 2 first-degree relatives with a histologically confirmed PC, or * 3 relatives of any degree with a histologically confirmed PC, one of whom must have been a first-degree relative, or * 2 relatives of any degree, one of whom was at least * 50 years at the time of diagnosis, with a histologically confirmed PC), apparently unrelated to any currently recognized hereditary syndrome
Clinical evidence of PC and / or PC in the medical history,
Medical comorbidities or coagulopathy that contraindicate endoscopy,
Medical comorbidities or coagulopathy that contraindicate pancreatic surgery,
Karnofsky performance score < 60
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Frequency of pancreatic cancer or precursor lesions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The false positive rate of surveillance strategy in FPC after resection surgery<br /><br><br /><br>Interobserver variability of endosonography in the surveillance of FPC<br /><br><br /><br>Interobserver variability of MRI in the surveillance of FPC<br /><br><br /><br>Cost-effectiveness of different surveillance scenarios in this population of<br /><br>cancer-prone individuals<br /><br><br /><br>Identification of novel biomarkers which accurately detect early pancreatic<br /><br>neoplasia.<br /><br><br /><br>Identification of unknown gene(s) responsible for the hereditary forms of PC<br /><br><br /><br>Determination of pancreatic neoplasia prevalence in known hereditary syndromes<br /><br>in order to improve risk stratification and provide more accurate estimates of<br /><br>individual cancer risk. </p><br>