NCT05284552 Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
| NCT ID | NCT05284552 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Linkoeping |
| Condition | Epithelial Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-07-12 |
| Primary Completion | 2027-12 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2022-07-12 with a primary completion date of 2027-12.
⚠ 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
Background: Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC). Study objectives: Primary objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive neoadjuvant chemotherapy (NACT). Secondary objectives: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described.
Eligibility Criteria
Inclusion Criteria: * The subject has given written consent to participate in the study. * Age 18 and above * Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum. * Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma. * FIGO stage III-IV disease. * Planned for platinum-based chemotherapy * Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test. * Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide). * WHO Performance Status 0-2 * Weight 50-150 kg * CA-125-level ≥250 kIE/L at diagnosis Exclusion Criteria: * Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed. * Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year. * Known or suspected allergies against any product included in the study * Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy * EOC disclosed at Cesarean section * Abdominal surgery or other major surgery within the last year * Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation * Treatment or disease which, according to the investigator, can affect treatment or study results * Known brain metastasis * Participation or recent participation (within the last 30 days) in a clinical study with an investigational product * Ongoing treatment of thromboembolic disease. * Thromboembolic disease within the last year. * Hypersensitivity to the active substance (tinzaparin) or any of the excipients. * Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria: 1. occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), 2. causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or 3. leads to transfusion of two or more units of whole blood or red blood cells. * Severe coagulation disorder. * Acute gastro duodenal ulcer. * Septic endocarditis. * Previous heparin-induced thrombocytopenia. * WHO Performance Status \>2. * E-GFR \<30ml/min (analyzed no more than 14 days before start of treatment with investigational product) * Platelets \<100 x10\^9/L (analyzed no more than 14 days before start of treatment with investigational product) * Treatment for other known malignancy within the last year (except basal cell carcinoma)
Contact & Investigator
Preben Kjölhede, MD, PhD
STUDY CHAIR
University Hospital, Linkoeping
Frequently Asked Questions
Who can join the NCT05284552 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Epithelial Ovarian 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 NCT05284552 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05284552 currently recruiting?
Yes, NCT05284552 is actively recruiting participants. Contact the research team at preben.kjolhede@regionostergotland.se for enrollment information.
Where is the NCT05284552 trial being conducted?
This trial is being conducted at Eksjö, Sweden, Gothenburg, Sweden, Jönköping, Sweden, Linköping, Sweden and 4 additional locations.
Who is sponsoring the NCT05284552 clinical trial?
NCT05284552 is sponsored by University Hospital, Linkoeping. The principal investigator is Preben Kjölhede, MD, PhD at University Hospital, Linkoeping. The trial plans to enroll 40 participants.
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