Using blood tests to evaluate surgery options for pancreatic cancer
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
This study is testing a blood test to see if it can help doctors decide if surgery is a good option for people with operable pancreatic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 1 site (Verona) |
| Trial ID | NCT05853198 on ClinicalTrials.gov |
What this trial studies
This study evaluates the prognostic value of circulating tumor DNA (ctDNA) as a marker for surgical futility in patients with operable pancreatic ductal adenocarcinoma (PDAC). It aims to identify a noninvasive blood test that can indicate the effectiveness of surgical resection based on tumor biology. Patients will undergo ctDNA analysis during various treatment courses to assess its efficacy as a predictive marker for treatment response. The goal is to improve decision-making regarding surgical interventions in PDAC patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with operable PDAC who are eligible for surgical resection.
Not a fit: Patients with non-resectable PDAC or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of surgical options for patients with pancreatic cancer, potentially improving outcomes.
How similar studies have performed: While the use of ctDNA as a biomarker is gaining traction, this specific application in PDAC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Verona
- AOUI Verona — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: antonio pea, MD PHD
- Email: antonio.pea@univr.it
- Phone: 0458124671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.