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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT06478056
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06478056
Study Brief:
Protocol Section:
NCT06478056