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

Primary Purpose

PDAC - Pancreatic Ductal Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ctDNA analysis
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PDAC - Pancreatic Ductal Adenocarcinoma focused on measuring biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AOUI VeronaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PDAC patients

Arm Description

PDAC patients as described in the inclusion criteria

Outcomes

Primary Outcome Measures

Disease relapse
disease relapse at 2 years after surgery

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 8, 2023
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT05853198
Brief Title
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
Acronym
CASPER
Official Title
Circulating Tumor DNA as Surgical Biomarker in Patients With PancrEatic Adenocarcinoma for Statement of Resectability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PDAC - Pancreatic Ductal Adenocarcinoma
Keywords
biomarker

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDAC patients
Arm Type
Other
Arm Description
PDAC patients as described in the inclusion criteria
Intervention Type
Other
Intervention Name(s)
ctDNA analysis
Intervention Description
ctDNA amount and mutations analysis
Primary Outcome Measure Information:
Title
Disease relapse
Description
disease relapse at 2 years after surgery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
antonio pea, MD PHD
Phone
0458124671
Email
antonio.pea@univr.it
Facility Information:
Facility Name
AOUI Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Venturini
Phone
0458124671
Email
elisa.venturini@univr.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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