Pancreatic Cancer Surveillance in CDKN2A and Other High Risk Mutation Carriers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27120

Enrollment

280

Registered

2020-12-14

Start date

2021-02-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Annual magnetic resonance imaging (MRI) with or without endoscopic ultrasound (EUS)

Eligibility

Inclusion criteria

Inclusion criteria: Participating in the PC surveillance program, which requires: • A proven CDKN2A or LKB1/STK11 mutation and = 40 years old • A proven BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, or MSH6 mutation with at least one affected first degree blood relative with pancreatic cancer and = 45 years old. • Screening for all mutation carriers ends at the age of 75 years.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The 5-year survival rate of patients with a CDKN2A mutation undergoing surveillance who develop PC.	—

Secondary

Measure	Time frame
1) The 5-year survival rate of individuals with other (non-CDKN2A) high risk mutations undergoing surveillance who develop PC. 2) The 10-year survival rate of all individuals with a high risk mutation undergoing surveillance who develop PC. 3) Identification of risk factors that predict neoplastic progression and development of PC. 4) The accuracy of MRI/MRCP and EUS for detecting neoplastic lesions, as compared to histology as a reference. 5) Ct-DNA: 5.1) The accuracy and feasibility of ct-DNA to detect PDAC 5.2) The correlation between ct-DNA levels and PC stage. 5.3) The correlation between ct-DNA with CEA and CA 19-9 tumormarkers 6) To explore the molecular profile of CDKN2A PDAC as compared to sporadic PDAC (PDAC occurring in the general population). 7) Assess the cost-effectiveness of pancreatic surveillance in high risk mutation carriers. 8) Exploration of psychological aspects of screening, including knowledge and perceptions of benefits and risks of genetic testing and surveillance.	—

Measure

Time frame

1) The 5-year survival rate of individuals with other (non-CDKN2A) high risk mutations undergoing surveillance who develop PC. 2) The 10-year survival rate of all individuals with a high risk mutation undergoing surveillance who develop PC. 3) Identification of risk factors that predict neoplastic progression and development of PC. 4) The accuracy of MRI/MRCP and EUS for detecting neoplastic lesions, as compared to histology as a reference. 5) Ct-DNA: 5.1) The accuracy and feasibility of ct-DNA to detect PDAC 5.2) The correlation between ct-DNA levels and PC stage. 5.3) The correlation between ct-DNA with CEA and CA 19-9 tumormarkers 6) To explore the molecular profile of CDKN2A PDAC as compared to sporadic PDAC (PDAC occurring in the general population). 7) Assess the cost-effectiveness of pancreatic surveillance in high risk mutation carriers. 8) Exploration of psychological aspects of screening, including knowledge and perceptions of benefits and risks of genetic testing and surveillance.

—

Contacts

Public ContactDerk Klatte

Leiden University Medical Center

d.c.f.klatte@lumc.nl071-526 3507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)