Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability

Study Overview
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Brief Summary
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The main objective is the evaluation of the prognostic value of ctDNA (circulating tumor DNA) as a marker of surgical futility in patients with operable PDAC.

Detailed Description
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In the era of personalized medicine and treatments guided by tumor biology, no specific tumor marker has real prognostic value. This is the reason why the search for a specific marker through a noninvasive blood test that can give indications on the usefulness of the resectability of pancreatic adenocarcinoma would be very valuable. Our project proposes the evaluation of ctDNA during various treatment courses of patients with PDAC in order to evaluate its efficacy as a prognostic and predictive marker of response to treatment.

Official Title
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Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability

Conditions
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PDAC - Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Other: ctDNA analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PDAC with indication to surgical resection, including those undergoing upfront surgery or surgery following induction treatment. Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice). Patients able to give a specific informed consent. Age ≥ 18 years. Exclusion Criteria: Non resectable patient defined as a patient with surgical indication at standard preoperative clinical, biological and morphological evaluation, but eventually not resected because of advanced disease or contraindications revealed during surgical exploration will be excluded (drop-out) Non-controlled congestive heart failure. Non-treated angina. Recent myocardial infarction (in the previous year). Non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment). Long QT. Major non-controlled infection. Severe liver failure. Age < 18 years. Informed consent not signed. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PDAC patients<br>PDAC patients as described in the inclusion criteria | Other: ctDNA analysis<br>* ctDNA amount and mutations analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease relapse | disease relapse at 2 years after surgery | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker