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

Integrated University Hospital Trust of Verona

Status: Enrolling

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

Treatments: Other: ctDNA analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05853198

3569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

PDAC patients

Other group

Description:

PDAC patients as described in the inclusion criteria

Treatment:

Other: ctDNA analysis