- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187416
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
Conditions
Intervention / Treatment
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
- Name: Kunlong Duan
- Phone Number: +8617795629885
- Email: 804868814@qq.com
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Ming Yu
- Phone Number: +8613991181250
- Email: yumingfmmu@126.com
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-
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
- Patients with resectable pancreatic cancer underwent ultrasound examination before surgery
- Conventional ultrasound can clearly show pancreatic space-occupying lesions and the elastic measurements show good images
- The patient agrees to receive ultrasound elasticity examination and signs informed consent
- All patients had no history of radiotherapy or chemotherapy before ultrasound examination
- All clinical case data and auxiliary examination data are complete and accessible.
Exclusion Criteria
- Ultrasound evaluation was not performed before ultrasound-guided needle biopsy
- Conventional ultrasound could not clearly show pancreatic space-occupying lesions or poor elastic measurement images
- Patients who refuse to accept examination or give up treatment
- Patients receiving neoadjuvant chemotherapy or radiotherapy before ultrasound examination
- 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20212175-C-1
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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