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

NCT05853198 | Recruiting

• 1 other identifier: 3569
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

• Disease relapse

  disease relapse at 2 years after surgery

  2 years

Study Arms (1)

PDAC patients

OTHER

PDAC patients as described in the inclusion criteria

Other: ctDNA analysis

Interventions

ctDNA analysis OTHER

ctDNA amount and mutations analysis

PDAC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37134, Italy

RECRUITING

Central Study Contacts

antonio pea, MD PHD

CONTACT

0458124671; antonio.pea@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 10, 2023
• Study Start: December 29, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (1)