NCT06155136

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

November 24, 2023

Last Update Submit

April 19, 2024

Conditions

Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • Disease characteristic according to age

    Tumor stage (localized/locally advanced/metastatic)

    Through study completion (approximatively 5 months)

Eligibility Criteria

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

Adult patients still alive one year after the initiation of NAliri

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Universität München, - Anstalt des öffentlichen Rechts -

Munich, 81377, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 4, 2023

Study Start

October 6, 2023

Primary Completion

March 30, 2024

Study Completion

September 30, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations

DE(1)