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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00199602
Eligibility Criteria:
Inclusion Criteria:
* First line chemotherapy for solid tumor with:
* Metastatic disease or
* Involved nodes or
* Unresectable tumor
* Indication for Implantable device for central venous access
* Potential survival \> 3 months
* ECOG performance status 0 to 2 (WHO)
* Age between 18 and 75 years.
* Social security guaranteed
* Normal laboratory assessments (platelets\> 100000/mm3, TP 60%, spontaneous TCA with M/T\<1.5, TGO and TGP \< 2xN, serum creatinin\<120µmol/l)
* Informed consent signed
Exclusion Criteria:
* Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
* Acute infectious endocarditis
* History related with heparin allergy or thrombopenia due to heparin
* Uncontrolled high blood pressure (systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg)
* Hemorrhagic syndrome ongoing
* Patient with platelet inhibitors treatment
* Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level
* Patient with liver failure (TP\<60%) or renal insufficiency (creatinin clearance\< 20 ml/mn)
* Women with pregnancy and lactating Pathology-related criteria
* deep venous thrombosis history or pulmonary embolism (\< 6 months)
* Clinical suspicious of brain metastasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00199602
Study Brief:
Protocol Section:
NCT00199602