Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma

NCT07664891 | Recruiting

• 1 other identifier: PROMETAP-IPC 2022-048
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Adenocarcinoma Metastatic

Outcome Measures

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.

  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.

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

Study Arms (3)

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

Biopsy collection OTHER

Tumor cells isolation

Group 2- Relapse; Groupe 1-Initial

Blood collection OTHER

Isolation of blood monocytes

Group 2- Relapse; Group 3- Biological; Groupe 1-Initial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy samples Blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jihane PAKRADOUNI

CONTACT

+334 91223778; drci.up@ipc-unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: June 24, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)