NCT04851106

Brief Summary

To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

4.2 years

First QC Date

April 15, 2021

Last Update Submit

April 17, 2024

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

  • The negative predictive value (NPV) determined from shear wave elastography

    12 months

Study Arms (1)

Patient with a solid pancreatic lesion of an undetermined nature

Patient with a solid pancreatic lesion of an undetermined nature

Diagnostic Test: Endoscopic ultrasound

Interventions

Endoscopic ultrasoundDIAGNOSTIC_TEST

Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.

Patient with a solid pancreatic lesion of an undetermined nature

Eligibility Criteria

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

Patient with a solid pancreatic mass of indeterminate origin

You may qualify if:

  • Patient over 18 years of age
  • Patient with a solid pancreatic mass of indeterminate origin

You may not qualify if:

  • Patient with ASA score 4 or 5
  • Patient with contraindication to SonoVue injection
  • Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rodica GINCUL

    Hôpital Jean Mermoz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodica GINCUL

CONTACT

0615340869rodica_h13@yahoo.fr

Study Design

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

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 20, 2021

Study Start

September 21, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)