Pancreatic cancer surveillance in CDKN2A and other high risk mutation carriers

Completed

Conditions: 'p16-Leiden'
pancreatic malignancy
10027664
10017991

Registration Number: NL-OMON50801

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

In order to be eligible to participate in this study, a subject must be
participating in the LUMC PC surveillance program, which requires:
- aged between 40 and 75, and
i) a proven CDKN2A or LKB1/STK11 mutation, regardless of family history, or
ii) a BRCA1/2, PALB2, ATM, MLH1/MSH2/MSH6 mutation with at least one first
degree relative with PC.

Exclusion Criteria

- Comorbidity leading to an impaired physical performance (World health
organization (WHO) performance status 3-4) or mental retardation.
- Life expectancy <5 years
- Very limited understanding of the Dutch or English language to be able to
make an informed choice.
- No informed consent.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the 5-year survival rate of patients with a CDKN2A<br /><br>mutation undergoing surveillance who develop PC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) The 10-year survival rate of individuals with a high risk mutationof<br /><br>patients with a CDKN2A mutation undergoing surveillance who develop PC.<br /><br>2) Identification of risk factors that predict neoplastic progression and<br /><br>development of PC.<br /><br>3) The accuracy of MRI/MRCP and EUS for detecting neoplastic lesions, as<br /><br>compared to histology as a reference.<br /><br>4.1) The accuracy and feasibility of ct-DNA to detect PDAC.<br /><br>4.2 The correlation between ct-DNA levels and PC stage.<br /><br>4.3) The correlation between ct-DNA with CEA and CA 19-9 tumormarkers.<br /><br>5) To explore the molecular profile of CDKN2A PDAC as compared to sporadic PDAC<br /><br>(PDAC occurring in the general population).<br /><br>6) Cost-effectiveness of pancreatic surveillance.<br /><br>7) Exploration of psychological aspects of screening, including knowledge and<br /><br>perceptions of benefits and risks of genetic testing and surveillance. </p><br>