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RecruitingNCT07664891Updated Jun 24, 2026

Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma

An observational study in Pancreatic Adenocarcinoma Metastatic, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Institut Paoli-Calmettes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

The present project aims to elucidate the metabolic interactions within the tumor microenvironment of pancreatic adenocarcinoma, both in the primary tumor and in hepatic and pulmonary metastatic sites, as well as in circulating blood biomarkers.

Deciphering these complex interactions aims to identify exploitable vulnerabilities for predicting treatment efficacy or for guiding therapeutic strategies.

Read the detailed description

Pancreatic adenocarcinoma (PDAC) remains one of the deadliest cancers, with survival rarely exceeding a few months and limited progress despite improved chemotherapy. Its poor prognosis is driven by late diagnosis, therapeutic resistance, and low responsiveness to targeted therapies and immunotherapy.

PDAC is characterized by a dense, immunosuppressive stroma and severe metabolic stress due to poor vascularization. Tumor progression relies heavily on stromal cells-such as cancer-associated fibroblasts and macrophages-as well as metabolic adaptations of cancer cells.

This project focuses on two key PDAC features to identify new biomarkers and therapeutic targets:

  • Stromal cell prevalence
  • Metabolic reprogramming
02

Conditions studied

  • Pancreatic Adenocarcinoma Metastatic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include adult men and women (≥18 years) diagnosed with metastatic pancreatic adenocarcinom

Eligibility criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Signed written informed consent specific to the PROMETAP study
  3. Affiliation with a social security system
  4. Treatment and follow-up performed at the Institut Paoli-Calmettes
  5. Metastatic PDAC requiring biopsy as part of routine care (group1 and 2)
  6. Prior treatment:

    • No previous chemotherapy for the "initial" group
    • No prior chemotherapy in the metastatic setting for the "Metastatic Relapse" group
  7. Eligible for chemotherapy (ECOG \< 2)

Non-Inclusion Criteria:

  1. Contraindication to biopsy of the pancreatic tumor or a hepatic or pulmonary metastasis (group 1 and 2)
  2. Absence of a metastasis accessible to biopsy (group1 and 2)
  3. Concurrent treatment for another active cancer
  4. Pregnant or breastfeeding women
  5. Patients in emergency situations

5. Adult individuals under legal protection (guardianship, trusteeship, judicial protection) or unable to provide informed consent

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Groupe 1-Initial

    Paired pancreatic and liver/lung metastatic biopsies will be used to establish primary and metastatic cell cultures from tumor specimens obtained during routine diagnostic procedures, along with peripheral blood samples, in a cohort of 12 patients

    Other: Biopsy collection · Other: Blood collection

  • Group 2- Relapse

    Biopsies of liver or lung metastases obtained at metastatic relapse or progression, along with peripheral blood samples, will be required from 12 patients for the establishment of primary and metastatic cell cultures.

    Other: Biopsy collection · Other: Blood collection

  • Group 3- Biological

    40 patient samples collected before chemotherapy and paired samples collected during chemotherapy will support molecular and cellular analyses aimed at identifying and assessing novel biomarkers and therapeutic strategies

    Other: Blood collection

Interventions

  • OtherBiopsy collection

    Tumor cells isolation

  • OtherBlood collection

    Isolation of blood monocytes

05

What researchers measure

Primary outcomes

  1. Evaluation and comparison of biological parameters reflecting metabolic alterations within the tumor microenvironment of pancreatic adenocarcinoma

    * Assessment of stromal dependency mechanisms; * Characterization and comparison of the metabolic profiles of primary pancreatic tumors and associated liver and lung metastases. These analyses aim to identify potential therapeutic targets and to explore diagnostic, prognostic, and predictive biomarkers of treatment response.

    Time frame: From sample collection to completion of analyses, estimated at 3 years

Secondary outcomes

  1. Exploratory characterization of metabolic pathways, tumor microenvironment features, and associated biomarkers in pancreatic adenocarcinoma.

    * Identification of prognostic markers of therapeutic response originating from the tumor microenvironment. * Identification of mechanisms of resistance to anti-tumor treatments linked to the microenvironment. * Identification of new therapeutic strategies capable of specifically targeting the tumor microenvironment.

    Time frame: From sample collection to completion of analyses, estimated at 3 years

06

Study locations

1 of 1 sites recruiting
  • Institut Paoli-Calmettes
    Marseille, 13009, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07664891
Lead sponsor
Institut Paoli-Calmettes
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
Sep 11, 2025
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jun 24, 2026

Study contacts

Jihane PAKRADOUNI
Contact
drci.up@ipc-unicancer.fr
+334 91223778

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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