A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma

Pancreas Cancer Clinical Trial

Official title:

Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997147
• Other study ID #: Panc-LVI-2023810
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jihui Hao, Dr
• Phone: +8618622221120
• Email: haojihui[@]tjmuch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1009
• Est. completion date: August 30, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who were pathologically diagnosed as PDAC and received curative surgery.

Exclusion Criteria:

• Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms
• Predictive Cancer Model

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	Time from operation to the detection of recurrence or last follow-up	10 years
Secondary	Overall survival	Time between surgical resection to death or the last follow-up.	10 years