NCT05899465 Perioperative Treatment With Tranexamic Acid in Melanoma
| NCT ID | NCT05899465 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Aarhus |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,204 participants |
| Start Date | 2023-08-25 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 1,204 participants in total. It began in 2023-08-25 with a primary completion date of 2026-09-01.
⚠ 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
Surgery is a key element in the treatment of melanoma, and naturally linked with an inflammatory response and recruitment of innate immune cells. Although surgery has a favorable intent, surgery-induced inflammation, neutrophils in particular, may accelerate growth of local and systemic micrometastases. Thus, improving cancer surgery and modulating the wound microenvironment in ways that benefit the patients is crucial. Repurposing already approved drugs in a cancer setting has gained increasing interest in recent years. Interestingly, tranexamic acid was recently suggested as an anti-cancer drug, capable of reducing tumor growth in experimental animal models and reducing the viability of different melanoma cell lines. As a novel approach, sponsor and investigators will conduct a Randomised Clinical Trial, using perioperative treatment with Tranexamic Acid, aiming to prevent the early relapses for patients with melanoma.
Eligibility Criteria
Inclusion Criteria: Patients * Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade ≥T2b), defined as either: Breslow thickness \>1.0-2.0 mm with presence of ulceration or Breslow thickness \>2.0 mm regardless of ulceration status. * Eligible for surgery (wide local excision and sentinel lymph node biopsy). * \>/=18 years of age and \</=80 years of age * Signed Informed Consent Form Exclusion Criteria: Patients * With a prior history of invasive melanoma * Thromboembolic events within the last 3 months * Pregnancy * Active breastfeeding * Known allergy or hypersensitivity to TXA * Known and treated epilepsia or previous seizures * eGFR 0-50 * Current use of tranexamic acid
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05899465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Melanoma. 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 NCT05899465 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 1,204 participants.
Is NCT05899465 currently recruiting?
Yes, NCT05899465 is actively recruiting participants. Contact the research team at marboe@rm.dk for enrollment information.
Where is the NCT05899465 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Aalborg, Denmark, Copenhagen, Denmark, Herlev, Denmark and 1 additional location.
Who is sponsoring the NCT05899465 clinical trial?
NCT05899465 is sponsored by University of Aarhus. The trial plans to enroll 1,204 participants.
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