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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer (NCT05284552) is a Phase 2 interventional studying Epithelial Ovarian Cancer, sponsored by University Hospital, Linkoeping. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Epithelial Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Tinzaparin Injectable Solution

Subcutaneous injection

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Obstetrics and Gynecology, Highland Hospital
Eksjö, Eksjö, Sweden
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden
Department of Obstetrics and Gynecology, Ryhov County Hospital
Jönköping, Jönköping County, Sweden
Department of Oncology, Linköping University Hospital
Linköping, Linköping, Sweden
Department of Obstetrics and Gynaecology, Norrland University Hospital
Umeå, Umeå, Sweden
Department of Obstetrics and Gynecology, Värnamo Hospital
Värnamo, Värnamo, Sweden
Department of Obstetrics and Gynecology, Västervik Hospital
Västervik, Västervik, Sweden
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, Sweden

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05284552), the sponsor (University Hospital, Linkoeping), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05284552 clinical trial studying?

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 (N… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05284552?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05284552?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05284552. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05284552. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.