Status:
NOT_YET_RECRUITING
PICC-ports Versus Chest - Ports for Long Term Chemotherapy Deliverance in Oncology Patients
Lead Sponsor:
European Institute of Oncology
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Central venous access devices are extensively used in oncology patients. The current standard is represented by devices inserted by direct ultrasound guided cannulation of deep veins of supra/infracla...
Detailed Description
Central venous access devices are extensively used in oncology patients who need safe deliverance of chemotherapeutic agents and drugs, transfusion of blood and blood products, and performance of labo...
Eligibility Criteria
Inclusion
- ≥ 18 Age ≤ 75 yrs
- Histologic diagnosis of a solid tumour
- Need for intravenous , long term (\> 3 months), intermittent chemotherapy (either adjuvant or palliative)
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
Exclusion
- Active infections
- Coagulopathy, defined as platelet count \< 50,000/μL and/or Prothrombin time (PT)/International Normalized Ratio (INR) \> 1.5
- Chronic severe renal failure, stage 3b-4-5 or imminent need for a dialysis fistula
- Any conditions contraindicating chemotherapy treatments, as valued by treating oncologist
- Life expectancy \< 6 months, as valued by treating oncologist
- Inability to give an informed consent and/or history of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
852 Patients enrolled
Trial Details
Trial ID
NCT06541301
Start Date
December 1 2024
End Date
February 1 2026
Last Update
November 19 2024
Active Locations (3)
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1
CRO (Centro di Riferimento Oncologico)
Aviano, Italy, 33081
2
Ospedale Careggi
Florence, Italy, 50134
3
European Institute of Oncology
Milan, Italy, 20141