PDAC - Pancreatic Ductal AdenocarcinomaPanC-YOUNGNCT05845801
Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer
An observational study of PDAC - Pancreatic Ductal Adenocarcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Register
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 7 Dec 2022to 30 Sep 2052
- How long will I take part?
- 30 Years
- 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 55 years
- All sexes
- Adult
Study population: The target population is represented by individuals who have received a pathological diagnosis of pancreatic cancer before the age of 55 years old (namely, EO-PDAC patients). No subject will be financially compensated for their participation.
Who may be able to join
- Age ≤55 years old at the time of diagnosis of pancreatic cancer
- Age ≥ 18 years
- Written informed consent obtained.
Who cannot join
- Any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor)
- Absence of informed consent.
- Age < 18 years or > 55 years old at the time of diagnosis of pancreatic cancer
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
AOUI Verona
Verona, 37134
Elisa Venturini, 0458124671, elisa.venturini@univr.it
About this study
The objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Being tested
- Register
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegisterOther
Prospective collection of epidemiological, clinical, and pathological data of patients diagnosed with early-onset pancreatic cancer (EO-PDAC) - namely, individuals who have received a diagnosis of pancreatic cancer before, or at, the age of 55 years old.
What is being measured
The primary outcome is the main question the study is designed to answer.
Register of young PDAC patients
Prospective collection of epidemiological, clinical, and pathological data of patients diagnosed with early-onset pancreatic cancer (EO-PDAC) - namely, individuals who have received a diagnosis of pancreatic cancer before, or at, the age of 55 years old.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Dec 2022
- Primary completion30 Sep 2052 (estimated)
- Study completion30 Sep 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845801
- Sponsor's protocol ID
- 3968
- Acronym
- PanC-YOUNG
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Young-Adult Patients Diagnosed With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05845801
- Acronym / sponsor ID
- PanC-YOUNG / 3968
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 30 Sep 2052 (estimated)
- Study completion
- 30 Sep 2052 (estimated)
- First posted
- 6 May 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 objective of the present registry is the creation of a prospective registry collecting clinico-pathological and genomic data, along with survival outcomes, of individuals diagnosed with PDAC at or before the age of 55 years old. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- The target population is represented by individuals who have received a pathological diagnosis of pancreatic cancer before the age of 55 years old (namely, EO-PDAC patients). No subject will be financially compensated for their participation.
Key inclusion criteria (3 listed)
- Age ≤55 years old at the time of diagnosis of pancreatic cancer
- Age ≥ 18 years
- Written informed consent obtained.
Key exclusion criteria (3 listed)
- Any pancreatic neoplasm other than pancreatic cancer (e.g. cholangiocarcinoma, ampullary cancer,duodenal cancer, non-invasive mucinous cystic neoplasm, pancreatic intra-epithelial neoplasia 1 and 2, non-invasive intraductal papillary mucinous neoplasm, serous cystic neoplasm, pseudo papillary solid tumor, neuroendocrine tumor)
- Absence of informed consent.
- Age < 18 years or > 55 years old at the time of diagnosis of pancreatic cancer
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 |
|---|---|---|
| RegisterProspective collection of epidemiological, clinical, and pathological data of patients diagnosed with early-onset pancreatic cancer (EO-PDAC) - namely, individuals who have received a diagnosis of pancreatic cancer before, or at, the age of 55 years old. | Other | – |
Primary outcome
Register of young PDAC patients
Time frame: 30 years
Prospective collection of epidemiological, clinical, and pathological data of patients diagnosed with early-onset pancreatic cancer (EO-PDAC) - namely, individuals who have received a diagnosis of pancreatic cancer before, or at, the age of 55 years old.
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 6 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PDAC - Pancreatic Ductal Adenocarcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona 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 3 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 6 May 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 Fabio Casciani (0458124671, fabio.casciani@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register of young PDAC patients (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023.