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

NCT ID: NCT05853198

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2026-05-31

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.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PDAC patients

PDAC patients as described in the inclusion criteria

Group Type: OTHER

ctDNA analysis

Intervention Type: OTHER

ctDNA amount and mutations analysis

Interventions

ctDNA analysis

ctDNA amount and mutations analysis

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOUI Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

antonio pea, MD PHD

Role: CONTACT

antonio.pea@univr.it

0458124671

Facility Contacts

Elisa Venturini

Role: primary

elisa.venturini@univr.it

0458124671

Other Identifiers

3569

Identifier Type: -

Identifier Source: org_study_id