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


2022-12-29


2026-05-31


2026-05-31


165

Study Overview

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

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.

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.

  • PDAC - Pancreatic Ductal Adenocarcinoma
  • OTHER: ctDNA analysis
  • 3569

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-04-18  

N/A  

2023-05-08  

2023-05-08  

N/A  

2023-05-10  

2023-05-10  

N/A  

2023-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: PDAC patients

PDAC patients as described in the inclusion criteria

OTHER: ctDNA analysis

  • ctDNA amount and mutations analysis
Primary Outcome MeasuresMeasure DescriptionTime Frame
Disease relapsedisease relapse at 2 years after surgery2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: antonio pea, MD PHD

Phone Number: 0458124671

Email: antonio.pea@univr.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. 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 2. Non-metastatic status confirmed by an abdomen CT-scan (as our routine clinical practice). 3. Patients able to give a specific informed consent. 4. Age ≥ 18 years.
    Exclusion Criteria:
    1. 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) 2. Non-controlled congestive heart failure. 3. Non-treated angina. 4. Recent myocardial infarction (in the previous year). 5. Non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment). 6. Long QT. 7. Major non-controlled infection. 8. Severe liver failure. 9. Age < 18 years. 10. Informed consent not signed. 11. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available