Candidates for Hereditary Pancreatic Cancer TestingPROPH-ITANCT05724992
Familial Pancreatic Cancer PROPHilation Program in Italy
A study testing Saliva swab testing in people with Candidates for Hereditary Pancreatic Cancer Testing, run by Associazione Italiana per lo Studio del Pancreas at 1 site in Italy.
Trial summary
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Candidates for Hereditary Pancreatic Cancer Testing
- What is being tested?
- Saliva swab testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2022to 20 Dec 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being enrolled on the IRFARPC registry
- Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
- Willingness to participate in saliva-swab-based genetic testing
Who cannot join
- Already known genetic mutation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata
Verona, 37136
Salvatore Paiella, MD, PhD, +390458126009, salvatore.paiella@univr.it
Erica Secchettin, PharmD, +390458126254, erica.secchettin@univr.it
About this study
Official title: Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.
Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.
Up to 3,000 participants will be enrolled in this study.
- Being tested
- Saliva swab testing
- Keywords
- Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance
- Medical subject headings
- Pancreatic Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva swab testingGenetic
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab
| Study group | Role | What they receive |
|---|---|---|
| Saliva testing swab | Other | Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing Receives: Genetic: Saliva swab testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence - absence of predisposing mutations
Prevalence of genetic mutations over the total tested
Measured: 5 years
Secondary outcomes (2)
Correlation of genetic mutations with personal oncological history
Correlation between presence of predisposing mutation and prevalence of cancers
Measured: 5 years
Correlation of genetic mutations with familial oncological history
Correlation between presence of predisposing mutation and prevalence of cancers in the family
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Dec 2022
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Candidates for Hereditary Pancreatic Cancer TestingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Italiana per lo Studio del Pancreas
- Sponsor type
- University, hospital or other
- Collaborators
- General and Pancreatic Surgery Unit, University of Verona, Fondazione Valsecchi, Associazione Oltre La Ricerca, Genomica srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724992
- Sponsor's protocol ID
- PROPH-ITA
- Acronym
- PROPH-ITA
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paiella S, Secchettin E, Archibugi L, De Luca R, Bonifacio C, Laghi L, Lionetto G, Milanetto AC, Sereni G, Coluccio C, Lauri G, Dal Buono A, Patruno M, Gabriel G, Sassatelli R, Binda C, Bonvissuto D, Uliana V, Malleo G, Cavestro GM, Terrin M, Martino S, Pasquali C, De Pastena M, De Cobelli F, Poletti V, Venturini E, Puzzono M, Zerbi A, Arcidiacono PG, Salvia R, Falconi M, Capurso G, Carrara S. Discovering Hereditary Risk Through Surveillance: A Prospective Genetic Analysis of Individuals With Familial Pancreatic Cancer. United European Gastroenterol J. 2026 Feb;14(1):e70187. doi: 10.1002/ueg2.70187.
PubMed 41691430
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05724992
- Acronym / sponsor ID
- PROPH-ITA / PROPH-ITA
- Keywords
- Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Associazione Italiana per lo Studio del PancreasUniversity, hospital or other
- Collaborators
- General and Pancreatic Surgery Unit, University of Verona, Fondazione Valsecchi, Associazione Oltre La Ricerca, Genomica srl
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 13 Feb 2023 (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.
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.
Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.
Up to 3,000 participants will be enrolled in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saliva testing swab | Other | Genetic: Saliva swab testingSubjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being enrolled on the IRFARPC registry
- Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
- Willingness to participate in saliva-swab-based genetic testing
Key exclusion criteria (1 listed)
- Already known genetic mutation
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 |
|---|---|---|
| Saliva swab testing41 pancreatic cancer predisposition genes will be tested through a saliva-based swab | Genetic | Saliva testing swab |
Primary outcome
Presence - absence of predisposing mutations
Time frame: 5 years
Prevalence of genetic mutations over the total tested
2 secondary outcomes
Correlation of genetic mutations with personal oncological history
Time frame: 5 years
Correlation of genetic mutations with familial oncological history
Time frame: 5 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 15 Feb 2023.
- Derived from this study: PubMed 41691430Paiella S, Secchettin E, Archibugi L, De Luca R, Bonifacio C, Laghi L, Lionetto G, Milanetto AC, Sereni G, Coluccio C, Lauri G, Dal Buono A, Patruno M, Gabriel G, Sassatelli R, Binda C, Bonvissuto D, Uliana V, Malleo G, Cavestro GM, Terrin M, Martino S, Pasquali C, De Pastena M, De Cobelli F, Poletti V, Venturini E, Puzzono M, Zerbi A, Arcidiacono PG, Salvia R, Falconi M, Capurso G, Carrara S. Discovering Hereditary Risk Through Surveillance: A Prospective Genetic Analysis of Individuals With Familial Pancreatic Cancer. United European Gastroenterol J. 2026 Feb;14(1):e70187. doi: 10.1002/ueg2.70187.
- Individual participant dataSharing planned: No
Related trials for Candidates for Hereditary Pancreatic Cancer Testing
Active, not recruiting
GENetic Education Risk Assessment and TEsting Study
Candidates for Hereditary Pancreatic Cancer Testing
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva swab testing in people with Candidates for Hereditary Pancreatic Cancer Testing, run by Associazione Italiana per lo Studio del Pancreas at 1 site 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 3 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Erica Secchettin, PharmD (0458126254, familiarita.aisp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence - absence of predisposing mutations (time frame: 5 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 NCT05724992, which also lists 1 linked publication.
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 15 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.