Familial Pancreatic CancerIRFARPCNCT04095195
Registry of Subjects at Risk of Pancreatic Cancer
An observational study of Familial Pancreatic Cancer and BRCA1 Mutation, run by Associazione Italiana per lo Studio del Pancreas at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- MRCP and Endoultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 4 sitesItaly
- Study dates
- 20 Aug 2019to 20 Sep 2045
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.
Who may be able to join
- 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
Show all 9Show fewer
- 45 years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases
- 40 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
- 30 years for subjects suffering from FAMMM, Peutz-Jeghers syndrome
Who cannot join
- pregnancy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
San Raffele Vita Salute University Hospital
Milan
Massimo Falconi, MD, massimo.falconi@hsr.it
Gabriele Capurso, MD, PhD
- Recruiting
Ospedale Pederzoli
Peschiera del Garda, Verona
Giovanni Butturini, MD
Alessandro Giardino, MD, PhD
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milan
Silvia Carrara, MD, silvia.carrara@humanitas.it
Alessandro Zerbi, MD
- Recruiting
Chirurgia Generale e del Pancreas
Verona, 37134
Salvatore Paiella, MD, PhD, 00390458126009, salvatore.paiella@univr.it
Erica Secchettin, PharmD, 00390458126254, erica.secchettin@univr.it
About this study
Official title: Italian Registry of Families At Risk of Pancreatic Cancer
IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.
Read the detailed description
Pancreatic cancer is a devastating disease with a dismal prognosis. One of the ways to improve survival might be early detection.
Within years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide.
A registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions.
Inclusion criteria will be adopted as "enrollment criteria". According to this, individuals > 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. Thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to Cholangio-Wirsung Magnetic Resonance or Pancreatic Endoultrasonography according to the pancreatologist's prescription at each participating center.
Individuals suffering from the following conditions will be enrolled:
familial pancreatic cancer; Peutz-Jeghers syndrome; a known BRCA-2, BRCA-1, PALB2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; FAMMM syndrome; Lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.
- Conditions
- Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation, Lynch Syndrome, FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome, Hereditary Pancreatitis
- Being tested
- MRCP, Endoultrasonography
- Keywords
- Familial Pancreatic Cancer, BRCA Mutation, Lynch Syndrome, Screening pancreatic cancer, Surveillance pancreatic cancer
- Medical subject headings
- Pancreatic carcinoma, familial, Colorectal Neoplasms, Hereditary Nonpolyposis, Dysplastic Nevus Syndrome, Hereditary pancreatitis, Peutz-Jeghers Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRCPRadiation
Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription
EndoultrasonographyProcedure or surgery
Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription
| Study group | Role | What they receive |
|---|---|---|
| Familial pancreatic cancer relatives | Not described Receives: Radiation: MRCP; Procedure: Endoultrasonography | |
| Peutz-Jeghers syndrome | Not described Receives: Radiation: MRCP; Procedure: 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 Receives: Radiation: MRCP; Procedure: Endoultrasonography | |
| Lynch syndrome with familiarity for pancreatic cancer | Not described Receives: Radiation: MRCP; Procedure: Endoultrasonography | |
| FAMMM syndrome | Not described Receives: Radiation: MRCP; Procedure: Endoultrasonography | |
| Hereditary and genetic pancreatitis | Not described Receives: Radiation: MRCP; Procedure: Endoultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start20 Aug 2019
- Primary completion20 Aug 2044 (estimated)
- Study completion20 Sep 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Familial Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Italiana per lo Studio del Pancreas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095195
- Sponsor's protocol ID
- IRFARPC
- Acronym
- IRFARPC
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30538291Paiella 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.
PubMed 37787643
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry of Families At Risk of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04095195
- Acronym / sponsor ID
- IRFARPC / IRFARPC
- Conditions
- Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation, Lynch Syndrome, FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome, Hereditary Pancreatitis
- Keywords
- Familial Pancreatic Cancer, BRCA Mutation, Lynch Syndrome, Screening pancreatic cancer, Surveillance pancreatic cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Associazione Italiana per lo Studio del PancreasUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 20 Aug 2044 (estimated)
- Study completion
- 20 Sep 2045 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.
Detailed description
Pancreatic cancer is a devastating disease with a dismal prognosis. One of the ways to improve survival might be early detection.
Within years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide.
A registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions.
Inclusion criteria will be adopted as "enrollment criteria". According to this, individuals > 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. Thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to Cholangio-Wirsung Magnetic Resonance or Pancreatic Endoultrasonography according to the pancreatologist's prescription at each participating center.
Individuals suffering from the following conditions will be enrolled:
familial pancreatic cancer; Peutz-Jeghers syndrome; a known BRCA-2, BRCA-1, PALB2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; FAMMM syndrome; Lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Familial pancreatic cancer relatives | – | Radiation: MRCP, Procedure: Endoultrasonography |
| Peutz-Jeghers syndrome | – | Radiation: MRCP, Procedure: Endoultrasonography |
| BRCA 1/2, PALB2, p16 mutations with familiarity for PC | – | Radiation: MRCP, Procedure: EndoultrasonographyKnown genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC |
| Lynch syndrome with familiarity for pancreatic cancer | – | Radiation: MRCP, Procedure: Endoultrasonography |
| FAMMM syndrome | – | Radiation: MRCP, Procedure: Endoultrasonography |
| Hereditary and genetic pancreatitis | – | Radiation: MRCP, Procedure: Endoultrasonography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRCPSubjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription | Radiation | BRCA 1/2, PALB2, p16 mutations with familiarity for PC, FAMMM syndrome, Familial pancreatic cancer relatives, Hereditary and genetic pancreatitis, Lynch syndrome with familiarity for pancreatic cancer, Peutz-Jeghers syndrome |
| EndoultrasonographySubjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription | Procedure or surgery | BRCA 1/2, PALB2, p16 mutations with familiarity for PC, FAMMM syndrome, Familial pancreatic cancer relatives, Hereditary and genetic pancreatitis, Lynch syndrome with familiarity for pancreatic cancer, Peutz-Jeghers syndrome |
Primary outcome
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
Time frame: 25 years
Number of malignant and pre-malignant lesions diagnosed over time
1 secondary outcome
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
Time frame: 25 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Results publication: PubMed 30538291Paiella 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.
- Derived from this study: PubMed 37787643Paiella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Pancreatic Cancer and BRCA1 Mutation, run by Associazione Italiana per lo Studio del Pancreas at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Paiella, MD, PhD (00390458126009, salvatore.paiella@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095195, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.