- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853198
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability (CASPER)
May 8, 2023 updated by: Azienda Ospedaliera Universitaria Integrata Verona
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
165
Phase
- Not Applicable
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
Study Locations
-
-
-
Verona, Italy, 37134
- Recruiting
- AOUI Verona
-
Contact:
- Elisa Venturini
- Phone Number: 0458124671
- Email: elisa.venturini@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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
- Long QT.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PDAC patients
PDAC patients as described in the inclusion criteria
|
ctDNA amount and mutations analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease relapse
Time Frame: 2 years
|
disease relapse at 2 years after surgery
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start (Actual)
December 29, 2022
Primary Completion (Anticipated)
May 31, 2026
Study Completion (Anticipated)
May 31, 2026
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 10, 2023
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3569
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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