Pancreatic Cancer Lifestyle Evolution And Resistance

Sponsor
IRCCS San Raffaele
Study ID
NCT07794969
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Ultrasound with FNA/FNB — PROCEDURE
    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.

Study Details

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: 1. transcriptome patterns linked to treatment response; 2. effects of smoking and microplastic exposure on treatment outcomes; 3. PDAC evolution across organ sites and under chemotherapy. These studies will help uncover biomarkers and factors shaping disease progression, hence paving the ground for personalized therapies.

Key Dates

First listed
Aug 31, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Patients with pancreatic adenocarcinoma
    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).

Primary Outcome Measure

Response to treatment at 6 months [ Time Frame: 6 months ]

Central Contacts

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