RWE On Patients With MPDAC Long-term Survival After Treatment With Liposomal Irinotecan

Study Overview

RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan

The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

The objectives on patients still alive one year after the first cycle of nal-IRI : * Characterize mPDAC patient population according to their demographics * Identify PDAC treatment by line of treatment from diagnosis to last treatment * Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Pancreatic Cancer Metastatic

DIM-95013-001-INT

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-19
First Submitted that Met QC Criteria 2023-11-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-22
First Posted (ACTUAL) 2023-12-04	Results First Posted N/A	Last Verified 2024-04

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Disease characteristic according to age	Tumor stage (localized/locally advanced/metastatic)	Through study completion (approximatively 5 months)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Age ≥ 18 years (≥ 19 years in South Korea)
Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
At least one cycle of nal-IRI-containing regimen should have been administered
A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
Availability of data related to survival outcomes in the patient medical record
Patients deceased or not at the time of enrollment will be eligible for inclusion in the study

No documentation of systemic therapy outcomes or prior treatments in patient medical records
Patients with second concomitant metastatic malignancy

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record