NCT04095195

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
236mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2019Sep 2045

Study Start

First participant enrolled

August 20, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
24.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2044

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2045

Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

25 years

First QC Date

September 17, 2019

Last Update Submit

January 12, 2023

Conditions

Familial Pancreatic CancerBRCA1 MutationBRCA2 MutationLynch SyndromeFAMMM - Familial Atypical Mole Malignant Melanoma SyndromeHereditary PancreatitisPeutz-Jeghers Syndrome

Keywords

Familial Pancreatic CancerBRCA MutationLynch SyndromeScreening pancreatic cancerSurveillance pancreatic cancer

Outcome Measures

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

    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

    25 years

Study Arms (6)

Familial pancreatic cancer relatives

Radiation: MRCPProcedure: Endoultrasonography

Peutz-Jeghers syndrome

Radiation: MRCPProcedure: Endoultrasonography

BRCA 1/2, PALB2, p16 mutations with familiarity for PC

Known genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC

Radiation: MRCPProcedure: Endoultrasonography

Lynch syndrome with familiarity for pancreatic cancer

Radiation: MRCPProcedure: Endoultrasonography

FAMMM syndrome

Radiation: MRCPProcedure: Endoultrasonography

Hereditary and genetic pancreatitis

Radiation: MRCPProcedure: Endoultrasonography

Interventions

MRCPRADIATION

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

BRCA 1/2, PALB2, p16 mutations with familiarity for PCFAMMM syndromeFamilial pancreatic cancer relativesHereditary and genetic pancreatitisLynch syndrome with familiarity for pancreatic cancerPeutz-Jeghers syndrome
EndoultrasonographyPROCEDURE

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

BRCA 1/2, PALB2, p16 mutations with familiarity for PCFAMMM syndromeFamilial pancreatic cancer relativesHereditary and genetic pancreatitisLynch syndrome with familiarity for pancreatic cancerPeutz-Jeghers syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • subjects suffering from PRSS-1- or CFTR- or SPINK-1- related pancreatitis
  • subjects suffering from Lynch syndrome with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer
  • years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases
  • years or 5 years younger than the youngest index case of pancreatic cancer for subjects suffering from hereditary/genetic pancreatitis, Lynch syndrome, or carrying a known BRCA 1/2, PALB2, p16 genetic mutation with familiarity for pancreatic cancer
  • years for subjects suffering from FAMMM, Peutz-Jeghers syndrome

You may not qualify if:

  • \- pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

RECRUITING

Ospedale Pederzoli

Peschiera del Garda, Verona, Italy

RECRUITING

San Raffele Vita Salute University Hospital

Milan, Italy

RECRUITING

Chirurgia Generale e del Pancreas

Verona, 37134, Italy

RECRUITING

Related Publications (2)

  • Paiella S, Capurso G, Cavestro GM, Butturini G, Pezzilli R, Salvia R, Signoretti M, Crippa S, Carrara S, Frigerio I, Bassi C, Falconi M, Iannicelli E, Giardino A, Mannucci A, Laghi A, Laghi L, Frulloni L, Zerbi A. Results of First-Round of Surveillance in Individuals at High-Risk of Pancreatic Cancer from the AISP (Italian Association for the Study of the Pancreas) Registry. Am J Gastroenterol. 2019 Apr;114(4):665-670. doi: 10.1038/s41395-018-0414-z.

    PMID: 30538291RESULT

  • Paiella S, Capurso G, Carrara S, Secchettin E, Casciani F, Frigerio I, Zerbi A, Archibugi L, Bonifacio C, Malleo G, Cavestro GM, Barile M, Larghi A, Assisi D, Fantin A, Milanetto AC, Fabbri C, Casadei R, Donato G, Sassatelli R, De Marchi G, Di Matteo FM, Arcangeli V, Panzuto F, Puzzono M, Dal Buono A, Pezzilli R, Salvia R, Rizzatti G, Casadio M, Franco M, Butturini G, Pasquali C, Coluccio C, Ricci C, Cicchese N, Sereni G, de Pretis N, Stigliano S, Rudnas B, Marasco M, Lionetto G, Arcidiacono PG, Terrin M, Crovetto A, Mannucci A, Laghi L, Bassi C, Falconi M. Outcomes of a 3-Year Prospective Surveillance in Individuals at High Risk of Pancreatic Cancer. Am J Gastroenterol. 2024 Apr 1;119(4):739-747. doi: 10.14309/ajg.0000000000002546. Epub 2023 Oct 3.

    PMID: 37787643DERIVED

MeSH Terms

Conditions

Pancreatic carcinoma, familialColorectal Neoplasms, Hereditary NonpolyposisDysplastic Nevus SyndromeHereditary pancreatitisPeutz-Jeghers Syndrome

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNevusNevi and MelanomasNeoplasms by Histologic TypeIntestinal PolyposisLentigoMelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Salvatore Paiella, MD, PhD

CONTACT

00390458126009salvatore.paiella@univr.it

Silvia Carrara, MD

CONTACT

+ 39 02 82247288silvia.carrara@humanitas.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

August 20, 2019

Primary Completion (Estimated)

August 20, 2044

Study Completion (Estimated)

September 20, 2045

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)