An observational study in Pancreatic Cancer, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by IRCCS San Raffaele · Observational
Advanced PDAC patients undergo polychemotherapy, yet responses are highly variable. Transcriptome signatures are emerging as key predictors of treatment response. However, PDAC adapts across sites (primary vs. metastases) and evolves under treatment pressure (pre- vs. post-chemotherapy). Moreover, common environmental pollutants, like smoking and microplastics, contribute to carcinogenesis, yet their impact on PDAC evolution and treatment response remains unclear.
To fill these gaps, the CLEAR project aims at investigating:
This study aims at identifying and validating transcriptome signatures in patients with Pancreatic Ductal Adenocarcinoma (PDAC) through EUS-guided biopsies. The study hypothesis is that specific molecular profiles (e.g., "basal-like" vs. "classical" subtypes) obtained at the time of diagnosis can predict primary resistance or sensitivity to standard-of-care first-line chemotherapy regimens (mFOL, NG, or PAXG). By correlating these signatures with clinical outcomes, the study seeks to provide a rationale for personalized therapeutic strategies in advanced PDAC.
This is a prospective, single-center, interventional study. Patients with a cytological diagnosis of PDAC (confirmed via Rapid On-Site Evaluation - ROSE) during a standard-of-care EUS-TA are enrolled at baseline. A part of the citology sample is employed for research purpose (RNA-seq). Following the procedure, patients receive standard-of-care chemotherapy (mFOL, NG, or PAXG). The intervention consists of an additional biopsy pass performed during EUS at the time of re-staging after chemotherapy, exclusively for research purposes (RNA-seq). All patients undergo standard longitudinal clinical monitoring to assess Progression-Free Survival (PFS) and Overall Survival (OS) for a total period of 30 months or until death.
Primary Objective:
To identify baseline transcriptomic signatures associated with treatment response to mFOL, NG, and PAXG in advanced PDAC patients.
Primary Endpoint:
Response to treatment assessed every 3 months by RECIST 1.1 criteria and defined as Disease Control Rate at 6 months (DCR-6); Progression-Free Survival (PFS) and Overall Survival (OS) during the follow-up period.
Secondary Objectives:
To investigate the longitudinal evolution of PDAC signatures during treatment
Secondary Endpoints:
Comparison of transcriptome signatures between baseline EUS-biopsy and repeated biopsy after 6 months of treatment.
To evaluate the impact of active smoking on transcriptomic subtypes and treatment outcomes via correlation between smoking status and the distribution of classical vs. basal-like subtypes and clinical outcomes.
To compare signatures between primary and metastatic sites throughout the comparison of transcriptomic patterns between primary tumor and metastatic biopsy samples.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients (aged ≥18 years) with a clinical and/or radiological suspicion of Pancreatic Ductal Adenocarcinoma (PDAC) who are scheduled to undergo a diagnostic Endoscopic Ultrasound-guided Tissue Acquisition (EUS-TA) as part of their standard clinical pathway. The population will include both men and women, without restrictions on ethnicity. Including a 10% loss to follow-up, the planned cohort is 150 patients, evenly distributed among the three regimens (mFOL, NG or PAXG).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study population consists of adult patients (aged ≥18 years) with a clinical and/or radiological suspicion of Pancreatic Ductal Adenocarcinoma (PDAC) who are scheduled to undergo a diagnostic Endoscopic Ultrasound-guided Tissue Acquisition (EUS-TA) as part of their standard clinical pathway. The population will include both men and women, without restrictions on ethnicity. Including a 10% loss to follow-up, the planned cohort is 150 patients, evenly distributed among the three regimens (mFOL, NG or PAXG).
Procedure: Endoscopic Ultrasound with FNA/FNB
After identification of the mass lesion, a tumor sample will be acquired with a standard FNA/FNB needle, as the standard procedure requires. The sample will be taken and stored in a Eppendorf Tube of 1.5ml pre-filled with 300μL 1-Thioglycerol/Homogenization solution \_Promega® then stored in a 80°C freezer and transferred every 2 weeks to the CRB for subsequent RNA-seq.
Response to treatment at 6 months
Response to treatment assessed every 3 months by RECIST 1.1 criteria and defined as Disease Control Rate at 6 months (DCR-6)
Time frame: 6 months
Progression-Free Survival (PFS)
Time of disease progression (PFS)
Time frame: 30 months
Overall Survival
Overall Survival (OS) during the follow-up period.
Time frame: 30 months
No study locations are listed for this record.
Plan to share: Undecided — data might be shared upon reasonable requests
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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