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

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

— CASPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853198
• Other study ID #: 3569
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: antonio pea, MD PHD
• Phone: 0458124671
• Email: antonio.pea[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Other:
• ctDNA analysis
ctDNA amount and mutations analysis

Locations

Country	Name	City	State
Italy	AOUI Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease relapse	disease relapse at 2 years after surgery	2 years