Evaluation of an Early Radiomic Signature in Patients With Metastatic Pancreatic Adenocarcinoma Treated With First-line Chemotherapy (RADIOPAN)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris
Pancreatic cancer, which has a poor prognosis, is becoming increasingly common in industrialized countries. Chemotherapy is the main treatment available for metastatic disease. Response to chemotherapy is currently assessed using imaging to monitor changes in the size of lesions undergoing treatment. Radiomics is a new method of analyzing quantitative data extracted from imaging that can be used to develop prediction algorithms and evaluate response to treatment. There is little robust radiomics data available for evaluating response to first-line treatments for pancreatic adenocarcinoma. Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic adenocarcinoma is a cancer with a poor prognosis, and its incidence is increasing, particularly in industrialized countries. Systemic chemotherapy, the main treatment available, has improved survival in patients with metastatic pancreatic adenocarcinoma. Following the results of the study by Conroy et al., the combination of 5FU + oxaliplatin + irinotecan (FOLFIRINOX) is one of the standard first-line chemotherapy regimens for metastatic pancreatic adenocarcinoma.

The population of patients with metastatic pancreatic adenocarcinoma is heterogeneous, with different survival profiles. This is part of a multifactorial picture that is still poorly understood (molecular, terrain, other factors, etc.). Response to chemotherapy is currently assessed using the RECIST 1.1 method, which takes into account changes in the size of lesions during treatment. However, this method is sometimes limited, as it does not always take into account the underlying pathophysiology.

Radiomics consists of analyzing quantitative data extracted from imaging, which allows prediction algorithms to be developed. Several studies have suggested that tumor architecture could be a biomarker of response and survival in patients with esophageal, lung, or colorectal cancer.

A study of 41 patients with advanced pancreatic cancer treated with gemcitabine-based chemotherapy evaluated the impact of radiological architectural assessment on treatment response. The results showed that tumor size, asymmetry, and standard deviation of density at baseline were associated with progression-free survival, and that tumor size and standard deviation of density at baseline were associated with overall survival. These results remain to be confirmed in a larger population, hence the value of conducting our work with data from our database.

Our main hypothesis is that quantifying tumor-related architectural changes could enable early identification of patients who will not respond to treatment. The overall objective would be to tailor the therapeutic strategy to each individual patient.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with pancreatic cancer across all AP-HP hospitals. Data will be collected retrospectively from the AP-HP Clinical Data Warehouse (EDS).

Description

Inclusion Criteria:

  • Adult patients (≥18 years)
  • Diagnosis of acute alcoholic hepatitis (ICD10 C25) in a pathology report, followed by manual verification in clinical documents

Exclusion Criteria:

  • Patients younger than 18 years at diagnosis

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ADK
All adult patients diagnosed with pancreatic cancer at AP-HP hospitals, identified using ICD-10 codes (C25)
Drug: Patients treated with FOLFOX or FOLFIRINOX in first line
Treatment with FOLFOX or FOLFIRINOX (chemotherapy protocols) in first line
Drug: Patients treated with GEMCITABINE in first line
Treatment with GEMCITABINE (chemotherapy protocols) in first line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after diagnosis of pancreatic cancer
Time Frame: From diagnosis up to 7 years after
Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of pancreatic cancer, by integrating clinical, biological, histological and radiomics information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.
From diagnosis up to 7 years after

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Anna PELLAT, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAT23014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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