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

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05853198

Collaborator

(none)

165

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
PDAC - Pancreatic Ductal Adenocarcinoma	Other: ctDNA analysis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

165 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 29, 2022

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: PDAC patients PDAC patients as described in the inclusion criteria	Other: ctDNA analysis ctDNA amount and mutations analysis

Arm

Intervention/Treatment

Other: PDAC patients

PDAC patients as described in the inclusion criteria

Other: ctDNA analysis

ctDNA amount and mutations analysis

Outcome Measures

Primary Outcome Measures

Disease relapse [2 years]
disease relapse at 2 years after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUI Verona	Verona		Italy	37134

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda Ospedaliera Universitaria Integrata Verona

ClinicalTrials.gov Identifier:

NCT05853198

Other Study ID Numbers:

3569

First Posted:

May 10, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona

biomarker

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of May 10, 2023