NCT05187416

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

December 20, 2021

Last Update Submit

January 16, 2022

Conditions

Keywords

2D-SWE

Outcome Measures

Primary Outcomes (1)

  • Elastic modulus measured by Ultrasonic shear wave and tumor stromal component assessed by pathological analysis in pancreatic cancer

    Baseline (Preoperative ultrasound elastography examination)

Interventions

Preoperative ultrasound elastography examination

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive cases of pancreatic cancer in Xijing Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 11, 2022

Study Start

February 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 19, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations