Health TrialsbyHealthPanel

Registry of Subjects at Risk of Pancreatic Cancer

ConditionsFamilial Pancreatic CancerBRCA1 MutationBRCA2 MutationLynch SyndromeFAMMM - Familial Atypical Mole Malignant Melanoma SyndromeHereditary PancreatitisPeutz-Jeghers Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAssociazione Italiana per lo Studio del Pancreas

About this trial

IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

individuals with at least two relatives suffering from pancreatic cancer, with at least 1 first-degree and until the third-degree

subjects with known genetic mutation of BRCA2, BRCA1, p16, PALB2 with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer

subjects suffering from FAMMM Syndrome

subjects suffering from Peutz-Jeghers Syndrome

Disqualifiers

None

Trial population

Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRCP

    Radiation

    Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription

  • Endoultrasonography

    Procedure/Surgery

    Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription

Treatment groups

1,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Familial pancreatic cancer relatives2 interventions
Group B: Peutz-Jeghers syndrome2 interventions
Group C: BRCA 1/2, PALB2, p16 mutations with familiarity for PC2 interventions
Group D: Lynch syndrome with familiarity for pancreatic cancer2 interventions
Group E: FAMMM syndrome2 interventions
Group F: Hereditary and genetic pancreatitis2 interventions

Trial outcomes

Primary outcomes

1

This clinical study will assess the diagnostic yield of a clinical surveillance program for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals

Number of malignant and pre-malignant lesions diagnosed over time

Time frame
25 years

Secondary outcomes

1

This study will investigate possible risk factors for the incidence or the progression of for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals

Identification of risk factors for malignant or pre-malignant lesions diagnosis

Time frame
25 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Associazione Italiana per lo Studio del Pancreas

Lead sponsor

Source ClinicalTrials.gov
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