NCT05407987 Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
| NCT ID | NCT05407987 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Gynecologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 82 participants in total. It began in 2025-04-08 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates. This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia. The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent prior to initiation of any study specific activities/procedures. 2. Age ≥ 18 years old. 3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion: 1. The indication for the operation may be for suspected or proven gynecologic malignancy. 2. Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1. 3. The expected time from recruitment to surgery is 28-90 days. 4. Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%. 5. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation. 6. Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment). 7. WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment. 8. Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks. Exclusion Criteria: 1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%. 2. Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy). 3. Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients. 4. Temperature \>38C or patient on non-prophylactic antibiotics. 5. Known chronic liver disease or active hepatitis. 6. Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment. 7. Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range. 8. Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo). 9. Unfit for elective surgery. 10. Pregnancy or lactation. 1\. Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements. 11\. Cervical cancer with a clinical stage of 2A or greater.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05407987 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05407987 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 82 participants.
Is NCT05407987 currently recruiting?
Yes, NCT05407987 is actively recruiting participants. Contact the research team at Steven.Bisch@ahs.ca for enrollment information.
Where is the NCT05407987 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05407987 clinical trial?
NCT05407987 is sponsored by AHS Cancer Control Alberta. The trial plans to enroll 82 participants.
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