Correlation Between Elastic Modulus of Ultrasonic Shear Wave and Tumor Stromal Component in Pancreatic Cancer

January 16, 2022 updated by: Xijing Hospital
Pancreatic cancer is a gastrointestinal tumor with a high degree of malignancy. Currently, there are many first-line chemotherapy regimens in clinical practice, but the individual selection of chemotherapy regimens has not been unanimously recognized.This study is aimed at exploring the correlation between the two-dimensional shear wave elastography (2D - SWE) parameters and pancreatic cancer stromal elements proportion through an ultrasound scan for resectable pancreatic cancer cases and postoperative pathological specimen analysis. Then determine if the pancreatic cancer two-dimensional shear wave elastography can guide clinicians selecting chemotherapy scheme by predicting tumor stromal elements .These results are expected to provide an effective non-invasive diagnostic basis for individualized treatment of pancreatic cancer.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive cases of pancreatic cancer in Xijing Hospital

Description

Inclusion Criteria

  1. Patients with resectable pancreatic cancer underwent ultrasound examination before surgery
  2. Conventional ultrasound can clearly show pancreatic space-occupying lesions and the elastic measurements show good images
  3. The patient agrees to receive ultrasound elasticity examination and signs informed consent
  4. All patients had no history of radiotherapy or chemotherapy before ultrasound examination
  5. All clinical case data and auxiliary examination data are complete and accessible.

Exclusion Criteria

  1. Ultrasound evaluation was not performed before ultrasound-guided needle biopsy
  2. Conventional ultrasound could not clearly show pancreatic space-occupying lesions or poor elastic measurement images
  3. Patients who refuse to accept examination or give up treatment
  4. Patients receiving neoadjuvant chemotherapy or radiotherapy before ultrasound examination
  5. Incomplete clinical data and auxiliary examination data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer
Time Frame: Baseline (Preoperative ultrasound elastography examination)
Baseline (Preoperative ultrasound elastography examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

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 Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 16, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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