Evaluating tumor DNA in blood and fluid for pancreatic cancer

Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma

This study is testing if analyzing tumor DNA in blood and fluid can help doctors better understand pancreatic cancer and improve treatment for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rouen)
• Trial ID: NCT06478056 on ClinicalTrials.gov

What this trial studies

This study evaluates the prognostic significance of circulating tumor DNA (ctDNA) found in both peripheral and portal venous blood, as well as in peritoneal fluid, in patients with pancreatic adenocarcinoma. The research aims to enhance the understanding of tumor characteristics and improve treatment strategies through liquid biopsy techniques. By analyzing ctDNA, the study seeks to identify potential therapeutic targets and markers that could lead to better patient outcomes. The intervention involves pancreatectomy, which is the surgical removal of the pancreas.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with operable pancreatic adenocarcinoma, either resectable or borderline, who meet specific biological and performance criteria.

Not a fit: Patients with other active cancers, hematological malignancies, or uncontrolled cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with pancreatic cancer.

How similar studies have performed: While the use of ctDNA in liquid biopsies is a promising area of research, this specific approach in pancreatic adenocarcinoma is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* Patient with operable pancreatic adenocarcinoma (resectable or boderline with or without neoadjuvant therapy) with histological evidence or indirect diagnostic criteria (CA 19-9 Significant (≥ 200 U/ml), pancreatic hypodense lesion without differential diagnosis)
* Biological criteria: Neutrophils \> 1,500 cmm, platelet count \> 100,000 cmm, creatinine clearance (Cockroft and Gault equation) \> 60 ml/min, hemoglobin \> 10 g/dl.
* ECOG performance status 0 or 1
* Patient has read and understood the information letter and signed the non-opposition/consent form.
* For an adult unable to give consent: Representative of the adult who has read and understood the information letter and signed the consent form

Exclusion Criteria:

* Other active cancer or haematological malignancy
* Uncontrolled congestive heart failure - untreated angina pectoris; recent myocardial infarction (within the last year) - uncontrolled hypertension (SBP \> 160 mm or DBP \> 100 mm, despite optimal drug therapy), long QT.
* Uncontrolled major infections, chronic infectious diseases, immunodeficiency syndromes
* Premalignant hematological disorders, e.g. myelodysplastic syndrome
* Severe hepatic impairment
* Patients not registered with social security
* Pregnant, parturient or breast-feeding woman (a pregnancy test will be carried out unless there is a history of hysterectomy, tubal ligation or menopause)
* Person deprived of liberty by an administrative or judicial decision, or person placed under court protection, sub-guardianship or guardianship.
* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent him/her from giving informed consent.
* Treatment contraindicated for venous sampling

Where this trial is running

Rouen

• University Hospital, Rouen — Rouen, France (Recruiting)

Study contacts

• Study coordinator: Pauline TORTAJADA, Dr

Conditions Pancreatic Cancer