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

Azienda Ospedaliera Universitaria Integrata Verona1 site in 1 country165 target enrollmentDecember 29, 2022

ConditionsPDAC - Pancreatic Ductal Adenocarcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Enrollment: 165
Locations: 1
Primary Endpoint: Disease relapse
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 29, 2022

End Date

May 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Responsible Party

Sponsor

Eligibility Criteria

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).
•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.