RecruitingNot ApplicableNCT05853198

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

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrollment

165 participants

Start Date

Dec 29, 2022

Study Type

INTERVENTIONAL

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria11

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.