Development & Clinical Application of K-PaC Registry Version 2.0
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 6,923
- Locations
- 1
- Primary Endpoint
- Development and clinical use of a pancreatic cancer registry
Study Overview
Brief Summary
Development and clinical use of pancreatic cancer registry
- Development of K-PaC Registry v.2.0: Retrospective data integration from 2010 to 2022 and prospective data collection from more than 811 enrolled patients from 2023 to 2029
- Creation of clinical evidence (RWE) based on pancreatic cancer real-world data (RWD): 3 or more
Detailed Description
We plan to collect retrospective and prospective data based on medical data centered on EMR. ∙ This registry is built on EMR data containing specific information on medical provider records and patient health records. It is designed to enable the confirmation of specific treatment history and medical staff records, and to generate highly valid RWD-based evidence through EMR information such as accurate diagnosis of disease, treatment method, symptom changes, monitoring of lab data values, and patient status. ∙ Based on the built registry data, it is possible to conduct research based on evaluation of drug treatment and additional comparison of indications for elderly or poor general condition patients who are excluded from regular clinical trials, as well as research on diagnosis and prognosis. The clinical information and biomarkers of the prospective patient group are analyzed to evaluate the correlation with treatment response, overall and progression-free survival rates.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of pancreatic cancer
Exclusion Criteria
- •In cases where medical record review is not feasible
Outcomes
Primary Outcomes
Development and clinical use of a pancreatic cancer registry
Time Frame: From initial diagnosis to death
Development of K-PaC Registry v.2.0: Retrospective data integration from 2010 to 2022 and prospective data collection from more than 811 enrolled patients from 2023 to 2029Creation of clinical evidence (RWE) based on pancreatic cancer real-world data (RWD): 3 or more
Secondary Outcomes
- Assessing the association between pancreatic cancer biomarker markers and treatment response, overall and progression-free survival(From initial diagnosis to death)
Investigators
Sang Myung Woo
Head, Center for Liver and Pancreatobiliary Cancer
National Cancer Center, Korea