Metastatic Pancreatic CancerNCT05380414
Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
A study testing Tumor samples (archival FFPE and optional de novo biopsy) and blood samples in people with Metastatic Pancreatic Cancer and Advanced Pancreatic Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, Advanced Pancreatic Cancer
- What is being tested?
- Tumor samples (archival FFPE and optional de novo biopsy) and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- Male or female patient > 18 years
- metastatic or advanced PDAC
- Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
- Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
- Life expectancy > 3 months
- PS score 0 or 1.
Who cannot join
- Curative therapy available
- Any condition contraindicated with blood sampling procedures required by the protocol.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
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
Centre Léon Bérard
Lyon, 69373
Philippe CASSIER, MD, PhD, 0426556835, philippe.cassier@lyon.unicancer.fr
About this study
Official title: A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
- Being tested
- Tumor samples (archival FFPE and optional de novo biopsy) and blood samples
- Keywords
- Molecular screening, Genomic profiles, Transcriptomic profiles
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor samples (archival FFPE and optional de novo biopsy) and blood samplesBiological
Molecular screening
| Study group | Role | What they receive |
|---|---|---|
| Metastatic/advanced PDAC Patients | Experimental | Tumor samples Receives: Biological: Tumor samples (archival FFPE and optional de novo biopsy) and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
Measured: At the end of study (5 years)
Secondary outcomes (6)
Time from ICF signature to day 1 of next line of therapy
Measured: At day 1
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Measured: At the end of study (5 years)
Progression-Free Survival (PFS)
Measured: Up to 12 months
Best overall response (BoR)
Measured: Up to 12 months
Overall survival (OS)
Measured: Up to 12 months
Duration of response (DoR)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CASSIER, MD, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380414
- Sponsor's protocol ID
- ET21-399 GENOPANC
- Status last verified
- Mar 2026
- First submitted
- 10 May 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT05380414
- Acronym / sponsor ID
- ET21-399 GENOPANC
- Keywords
- Molecular screening, Genomic profiles, Transcriptomic profiles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 May 2022 (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 proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic/advanced PDAC Patients | Experimental | Biological: Tumor samples (archival FFPE and optional de novo biopsy) and blood samplesTumor samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient > 18 years
- metastatic or advanced PDAC
- Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
- Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
- Life expectancy > 3 months
Key exclusion criteria (4 listed)
- Curative therapy available
- Any condition contraindicated with blood sampling procedures required by the protocol.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
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 |
|---|---|---|
| Tumor samples (archival FFPE and optional de novo biopsy) and blood samplesMolecular screening | Biological | Metastatic/advanced PDAC Patients |
Primary outcome
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
Time frame: At the end of study (5 years)
6 secondary outcomes
Time from ICF signature to day 1 of next line of therapy
Time frame: At day 1
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Time frame: At the end of study (5 years)
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Best overall response (BoR)
Time frame: Up to 12 months
Overall survival (OS)
Time frame: Up to 12 months
Duration of response (DoR)
Time frame: Up to 12 months
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 31 Mar 2026.
Related trials for Metastatic Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
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.
Philippe CASSIER, MD, PhD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor samples (archival FFPE and optional de novo biopsy) and blood samples in people with Metastatic Pancreatic Cancer and Advanced Pancreatic Cancer, run by Centre Leon Berard 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 6 inclusion and 4 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 31 Mar 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 Philippe CASSIER, MD, PhD (0426556833, philippe.cassier@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial. (time frame: At the end of study (5 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 31 Mar 2026.