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

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05997147
Collaborator
(none)
1,009
Enrollment
1
Location
4
Anticipated Duration (Months)
253.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1009 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study
    Actual Study Start Date :
    May 1, 2023
    Actual Primary Completion Date :
    Aug 5, 2023
    Anticipated Study Completion Date :
    Aug 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence-free survival [10 years]

      Time from operation to the detection of recurrence or last follow-up

    Secondary Outcome Measures

    1. Overall survival [10 years]

      Time between surgical resection to death or the last follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060

    Sponsors and Collaborators

    • Tianjin Medical University Cancer Institute and Hospital

    Investigators

    • Study Chair: Jihui Hao, Dr, Tianjin Medical University Cancer Institute and Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Medical University Cancer Institute and Hospital
    ClinicalTrials.gov Identifier:
    NCT05997147
    Other Study ID Numbers:
    • Panc-LVI-2023810
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2023