- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664891
Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma
Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma: Identification of New Therapeutic Targets
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jihane PAKRADOUNI
- Phone Number: +334 91223778
- Email: drci.up@ipc-unicancer.fr
Study Locations
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-
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Marseille, France, 13009
- Recruiting
- Institut Paoli-Calmettes
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Contact:
- Jihane PAKRADOUNI
- Phone Number: +334 91223778
- Email: drci.up@ipc.unicancer.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Signed written informed consent specific to the PROMETAP study
- Affiliation with a social security system
- Treatment and follow-up performed at the Institut Paoli-Calmettes
- Metastatic PDAC requiring biopsy as part of routine care (group1 and 2)
Prior treatment:
- No previous chemotherapy for the "initial" group
- No prior chemotherapy in the metastatic setting for the "Metastatic Relapse" group
- Eligible for chemotherapy (ECOG < 2)
Non-Inclusion Criteria:
- Contraindication to biopsy of the pancreatic tumor or a hepatic or pulmonary metastasis (group 1 and 2)
- Absence of a metastasis accessible to biopsy (group1 and 2)
- Concurrent treatment for another active cancer
- Pregnant or breastfeeding women
- Patients in emergency situations
5. Adult individuals under legal protection (guardianship, trusteeship, judicial protection) or unable to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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Tumor cells isolation
Isolation of blood monocytes
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|
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.
|
Tumor cells isolation
Isolation of blood monocytes
|
|
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
|
Isolation of blood monocytes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation and comparison of biological parameters reflecting metabolic alterations within the tumor microenvironment of pancreatic adenocarcinoma
Time Frame: From sample collection to completion of analyses, estimated at 3 years
|
These analyses aim to identify potential therapeutic targets and to explore diagnostic, prognostic, and predictive biomarkers of treatment response. |
From sample collection to completion of analyses, estimated at 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory characterization of metabolic pathways, tumor microenvironment features, and associated biomarkers in pancreatic adenocarcinoma.
Time Frame: From sample collection to completion of analyses, estimated at 3 years
|
|
From sample collection to completion of analyses, estimated at 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROMETAP-IPC 2022-048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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