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Trial Title:
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
NCT ID:
NCT05853198
Condition:
PDAC - Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
biomarker
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
ctDNA analysis
Description:
ctDNA amount and mutations analysis
Arm group label:
PDAC patients
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AOUI Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa Venturini
Phone:
0458124671
Email:
elisa.venturini@univr.it
Start date:
December 29, 2022
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Azienda Ospedaliera Universitaria Integrata Verona
Agency class:
Other
Source:
Azienda Ospedaliera Universitaria Integrata Verona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853198
