PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
biomarker
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.
Interventions
OTHERctDNA analysis
ctDNA amount and mutations analysis
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease relapse | 2 years | disease relapse at 2 years after surgery |
Countries
Italy
Contacts
Primary Contactantonio pea, MD PHD
Outcome results
None listed