NCT05845801

Brief 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. This registry is intended with the aim of using collected data for future clinical trials, both prospective and retrospective.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
319mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress12%
Dec 2022Sep 2052

Study Start

First participant enrolled

December 7, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
29.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2052

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2052

Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

29.8 years

First QC Date

April 7, 2023

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 years

Interventions

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≤55 years old at the time of diagnosis of pancreatic cancer
  • Age ≥ 18 years
  • Written informed consent obtained.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI Verona

Verona, 37134, Italy

RECRUITING

MeSH Terms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 6, 2023

Study Start

December 7, 2022

Primary Completion (Estimated)

September 30, 2052

Study Completion (Estimated)

September 30, 2052

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations