Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
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
| Condition(s) | Epithelial Ovarian Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 N |
| Who can participate | 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 abstinenc |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | University Hospital, Linkoeping |
| Locations | Eksjö, Eksjö, Sweden; Gothenburg, Gothenburg, Sweden; Jönköping, Jönköping County, Sweden; Linköping, Linköping, Sweden; Umeå, Umeå, Sweden; Värnamo, Värnamo, Sweden (+2 more sites) |
| Start date | 2022-07-12 |
| NCT ID | NCT05284552 |
| Official listing | https://clinicaltrials.gov/study/NCT05284552 |