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2023-05-01
2023-08-05
2023-08-30
1009
NCT05997147
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
OBSERVATIONAL
A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-08-10 | N/A | 2023-08-10 |
2023-08-10 | N/A | 2023-08-18 |
2023-08-18 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Time from operation to the detection of recurrence or last follow-up | 10 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | Time between surgical resection to death or the last follow-up. | 10 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jihui Hao, Dr Phone Number: +8618622221120 Email: haojihui@tjmuch.com |
Study Contact Backup Name: Yiping Zou, Dr Phone Number: +8615875353255 Email: yiping-zou@foxmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
