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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05196334
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Histopathological confirmation of PDAC and planned standard first-line treatment prior to entering this study OR Patients suspected of primary locally advanced, non-metastatic PDAC based on cross-sectional imaging undergoing diagnostic standard of care (SOC) EUS-FNB procedure
* Age \> 18 years and older
* Life expectancy greater than 3 months
* ECOG/WHO Performance Status (PS) 0-1
* Patients must have normal organ and marrow function as defined below:
* White blood cell count (WBC) ≥ 3 x 10⁹/L
* Platelet count ≥ 100 x 10⁹/L
* Serum bilirubin ≤1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L)
* PP ≥ 40 or INR ≤ 1.5
* Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min (using the Cockcroft-Gault formula)
Exclusion Criteria:
* Contraindications for nurse administered propofol sedation (NAPS)
* Contraindications for EUS-FNB procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05196334
Study Brief:
Protocol Section:
NCT05196334