A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma
Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study
1 other identifier
observational
1,009
1 country
1
Brief Summary
Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients. Objective: To construct a preoperative model which could predict LVI in PDAC patients and further validate it in other cohorts. Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in this study. Univariate and multivariate Logistic regression analyses were conducted to define independent prediction factors of LVI. A nomogram was constructed based on the result of multivariate analysis.The predictive value of the model was assessed using receiver operating characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the cut-off point. The calibration plot was utilized to assess the concordance of the model. The decision curve analyses (DCA) were applied to estimate the clinical benefit of using this model to predict LVI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Shorter than P25 for all trials
1 active site
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 Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2023
CompletedFirst Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedAugust 18, 2023
August 1, 2023
3 months
August 10, 2023
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence-free survival
Time from operation to the detection of recurrence or last follow-up
10 years
Secondary Outcomes (1)
Overall survival
10 years
Eligibility Criteria
Patients who were pathologically diagnosed as PDAC and received curative surgery.
You may qualify if:
- Patients who were pathologically diagnosed as PDAC and received curative surgery.
You may not qualify if:
- Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jihui Hao, Dr
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 18, 2023
Study Start
May 1, 2023
Primary Completion
August 5, 2023
Study Completion
August 30, 2023
Last Updated
August 18, 2023
Record last verified: 2023-08