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

Not Applicable

Recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
• Interventions: Other: ctDNA analysis

• Registration Number: NCT05853198
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Study Timeline

• Study Start: 2022-12-29
• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDAC patients	ctDNA analysis	PDAC patients as described in the inclusion criteria

Primary Outcome Measures

Name	Time	Method
Disease relapse	2 years	disease relapse at 2 years after surgery

Trial Locations

Locations (1)

AOUI Verona; 🇮🇹 Verona, Italy