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Not Yet Recruiting
NCT05669872
Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
Conditions: Gynecologic Cancer
Sex: Female
Ages: 20 Years – 80 Years
Phase: NA
Enrollment: 334
Sponsor: Asan Medical Center
Location: Korea, Republic of
Summary
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
Eligibility Criteria
Inclusion Criteria:Women aged 20-80 yearsUntreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)Patients with ECOG performance status 0-2Patients with ASA PS 1-2Preoperative Hgb ≥ 7 g/dLPatients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)In case of showing proper organ function WBC ≥ 3,000/mm3 Platelets ≥ 100,000/mm3 Creatinine ≤ 2.0 mg/dL Bilirubin ≤ 1.5 x institutional upper limit normal SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normalPatient who voluntarily signed the informed consent formExclusion Criteria:Patient who unable to determine whether or not to consent on their ownPatients with serious underlying diseases or complicationsWomen who are pregnant or lactatingPatients with concurrent infectionPatients who are allergic to existing iron preparationsPatients who underwent neoadjuvant chemotherapy or preoperative radiation therapyPatients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladderPatients with iron overload or iron utilization disordersPatients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests
Source: ClinicalTrials.gov (NCT05669872). StuddyBuddy aggregates publicly available trial information.