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

NCT ID: NCT05997147

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1009 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Predictive Cancer Model Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jihui Hao, Dr

Role: STUDY_CHAIR

Tianjin Medical University Cancer Institute and Hospital

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jihui Hao, Dr

Role: CONTACT

+8618622221120

Yiping Zou, Dr

Role: CONTACT

+8615875353255

Facility Contacts

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Jihui Hao, Dr

Role: primary

+8618622221120

Other Identifiers

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Panc-LVI-2023810

Identifier Type: -

Identifier Source: org_study_id

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