To prospectively evaluate the feasibility and effectiveness of surveillance of individuals at high-risk for developing pancreatic cancer, in order to detect non-symptomatic (early) neoplastic lesions at a stage when curative resection is still…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of pancreatic cancer or precursor lesions.
Secondary outcome
The false positive rate of surveillance strategy in FPC after resection surgery
Interobserver variability of endosonography in the surveillance of FPC
Interobserver variability of MRI in the surveillance of FPC
Cost-effectiveness of different surveillance scenarios in this population of
cancer-prone individuals
Identification of novel biomarkers which accurately detect early pancreatic
neoplasia.
Identification of unknown gene(s) responsible for the hereditary forms of PC
Determination of pancreatic neoplasia prevalence in known hereditary syndromes
in order to improve risk stratification and provide more accurate estimates of
individual cancer risk.
Background summary
Pancreatic cancer (PC) is among the most fatal human cancers, in part because
of late diagnosis and a lack of effective therapies. At the time of diagnosis,
most patients have irresectable disease due to local vascular involvement or
distant metastases. In such cases the median survival is about 6 months. Thus,
for individuals at high risk of developing PC there is an urgent need for
effective surveillance methods. Aside from cigarette smoking, family history is
the only other well-established epidemiological risk factor in PC. About 10% of
cases are believed to be caused by inherited genetic factors and in some
instances the risk of developing pancreatic cancer can approach 50%. The
ability to surveil high-risk patients would significantly enhance the potential
for early diagnosis, thereby identifying the disease at an potentially curable
stage.
Study objective
To prospectively evaluate the feasibility and effectiveness of surveillance of
individuals at high-risk for developing pancreatic cancer, in order to detect
non-symptomatic (early) neoplastic lesions at a stage when curative resection
is still possible.
Study design
Yearly surveillance in this prospective protocol will be performed by EUS and
MRI. In case of abnormalities additional investigations will be performed
including EUS-FNA (tissue sampling). Blood samples and feces are collected to
search for potential tumormarkers in the screening of high-risk individuals.
Study burden and risks
Main burden of participation is a yearly follow-up investigational program
consisting of an endosonographic investigation, MR-scanning, blood sampling and
feces collection all of which are considered low-risk interventions. Major
benefits might occur when a precursor lesion or early PC is detected while it
is still resectable.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
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 | NL16302.018.07 |