NCT02674100

Brief Summary

The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions. The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
6 countries

16 active sites

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

Study Progress74%
Jan 2016Jan 2030

Study Start

First participant enrolled

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 25, 2025

Status Verified

December 1, 2024

Enrollment Period

14 years

First QC Date

January 29, 2016

Last Update Submit

February 23, 2025

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Prospective collection of All Adverse Events that will be categorized as either IRE related or Non-IRE related and will be graded per CTCAE v4.0

    Up to 5 years

Secondary Outcomes (1)

  • Overall Survival

    Up to 5 years

Interventions

RegistryOTHER

Eligibility Criteria

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

Any patient greater than 18 years of age that the treating physician believes that ablation of their soft tissue would be feasible in the care of their pancreatic cancer.

You may qualify if:

  • Adult patients (greater than 18 years of age) diagnosed with pancreatic cancer that are eligible for soft tissue ablation per the treating physician.

You may not qualify if:

  • Have a cardiac pacemaker or ICD implant
  • Non-removable implants with metal parts near target lesion
  • Myocardial infarction within 3 months prior to enrollment
  • Not suitable for general endotracheal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of California San Diego

San Diego, California, 92093, United States

RECRUITING

University of Colorado

Denver, Colorado, 80309, United States

RECRUITING

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

Atlantic Health

Millburn, New Jersey, 07041, United States

RECRUITING

Northwell Health Cancer Institute

Lake Success, New York, 11042, United States

RECRUITING

Gibbs Cancer Research, Spartanburg Regional Healthcare System

Spartanburg, South Carolina, 29303, United States

RECRUITING

Methodist Digestive Institute

Dallas, Texas, 75203, United States

RECRUITING

McGill University

Montreal, Quebec, Canada

RECRUITING

Sanno Hospital

Tokyo, Japan, 107-0052, Japan

RECRUITING

Centro Medico

Mexico City, Mexico

RECRUITING

National Taiwan University

Taipei, 10617, Taiwan

RECRUITING

Freeman Hospital

High Heaton, NE7 7DN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Registries

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert Martin, MD, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Martin, MD, PhD

CONTACT

502-629-3355robert.martin@louisville.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 4, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

February 25, 2025

Record last verified: 2024-12

Locations

GB(1)JP(1)CA(1)ME(1)US(11)TW(1)