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Pancreatic Cancer Lifestyle Evolution And Resistance

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age = 18 years

Willing to sign informed consent

Patient with CT scan or MRI or EUS with a lesion suspect of PDAC at any clinical stage

Patients considered fit to receive polychemotherapy with either mFOL, NG or PAXG.

Disqualifiers

Patients not willing to sign informed consent

Pregnancy and breastfeeding

Cytology positive for malignancies other than PDAC

Patients who have not performed biopsy for safety or technical reasons

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Ultrasound with FNA/FNB

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with pancreatic adenocarcinoma1 intervention

Trial outcomes

Primary outcomes

1

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
2

Progression-Free Survival (PFS)

Time of disease progression (PFS)

Time frame
30 months

Secondary outcomes

Other outcomes

1

Overall Survival

Overall Survival (OS) during the follow-up period.

Time frame
30 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: