Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT07034703
Eligibility Criteria:
Inclusion Criteria:
* Pancreatic adenocarcinoma, confirmed by a histocytological analysis
* Potentially resectable pancreatic adenocarcinoma (according to the NCCN classification; Version 2.2017). Resecability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon.
* No previous chemotherapy
* Age 18 or over
* PS Grade 0 or 1
* Absolute neutrophil count \> 1,500 mm3 platelet count \> 100,000 mm3 creatinine clearance (according MDRD equation) \> 50 ml/min, haemoglobin level \> 10 g/dl (transfusions are authorized)
* Women of child-bearing age not having undergone a hysterectomy or tubal ligation - requirement for a pregnancy test (abnormal serum or urine beta-HCG level) before inclusion.
* Provision of informed, written consent
Exclusion Criteria:
* Pancreatic adenocarcinoma defined as locally advanced non-resectable or metastatic.
* Dihydropyrimidine dehydrogenase complete deficiency (uracilemia ≥ 150 ng/ml)
* Surgical or anaesthesiological contra-indications:
* non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment), long QT
* major non-controlled infection
* severe liver failure
* Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data
* Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07034703
Study Brief:
Protocol Section:
NCT07034703