Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma

NCT06478056 | Completed

• 1 other identifier: 2021/0385/HP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood, portal venous blood, collected intraoperatively, as well as its detection in peritoneal fluid.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• level of ctDNA

  the level of ctDNA measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery

  Surgery

Secondary Outcomes (2)

• level of ctDNA

  surgery

• peritoneal ctDNA level

  surgery

Study Arms (1)

Surgery

OTHER

patients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital

Procedure: pancreatectomy

Interventions

pancreatectomy PROCEDURE

patients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital, Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 27, 2024
• Study Start: May 28, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)