Pancreatic Adenocarcinoma MetastaticNCT07664891
Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma
An observational study of Pancreatic Adenocarcinoma Metastatic, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma Metastatic
- What is being tested?
- Biopsy collection and Blood collection
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2025to 1 Sep 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult men and women (≥18 years) diagnosed with metastatic pancreatic adenocarcinom
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli-Calmettes
Marseille, 13009
Jihane PAKRADOUNI, +334 91223778, drci.up@ipc.unicancer.fr
About this study
Official title: 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.
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
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Being tested
- Biopsy collection, Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy collectionOther
Tumor cells isolation
Blood collectionOther
Isolation of blood monocytes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From sample collection to completion of analyses, estimated at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start11 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664891
- Sponsor's protocol ID
- PROMETAP-IPC 2022-048
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Reprogramming and Microenvironment in Pancreatic Adenocarcinoma: Identification of New Therapeutic Targets
- ClinicalTrials.gov ID
- NCT07664891
- Acronym / sponsor ID
- PROMETAP-IPC 2022-048
- Conditions
- Pancreatic Adenocarcinoma Metastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groupe 1-Initial | – | Other: Biopsy collection, Other: Blood collectionPaired 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 |
| Group 2- Relapse | – | Other: Biopsy collection, Other: Blood collectionBiopsies 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. |
| Group 3- Biological | – | Other: Blood collection40 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult men and women (≥18 years) diagnosed with metastatic pancreatic adenocarcinom
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy collectionTumor cells isolation | Other | Group 2- Relapse, Groupe 1-Initial |
| Blood collectionIsolation of blood monocytes | Other | Group 2- Relapse, Group 3- Biological, Groupe 1-Initial |
Primary outcome
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
* 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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma Metastatic, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihane PAKRADOUNI (+334 91223778, drci.up@ipc-unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.