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Study on the Effects of Tinzaparin on Biomarkers in Advanced Ovarian Cancer Patients Receiving Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called tinzaparin sodium in patients with advanced stages of ovarian cancer. Specifically, it involves patients with FIGO Stage III-IV epithelial ovarian cancer who are undergoing a type of treatment known as neoadjuvant chemotherapy. The purpose of the study is to evaluate how tinzaparin affects certain biological markers in the body, particularly a marker known as CA-125, which is often elevated in ovarian cancer patients.

Participants in the study will receive tinzaparin through subcutaneous injections, which means the medication is administered under the skin. The study will monitor changes in CA-125 levels before and during chemotherapy cycles, as well as before surgery. Additionally, other health indicators such as hemoglobin, platelets, and certain proteins will be measured throughout the treatment period. The study will also assess how well patients adhere to the tinzaparin injections and any side effects they may experience.

The trial is designed to provide valuable insights into the potential benefits of tinzaparin for ovarian cancer patients, particularly in managing the disease and improving treatment outcomes. By understanding the effects of tinzaparin on these biological markers, researchers hope to enhance the overall care and treatment strategies for individuals battling this challenging condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of epithelial ovarian cancer and ensuring you meet the inclusion criteria, such as age and weight requirements.
Step 3
Treatment plan
You will be scheduled to receive tinzaparin sodium through a subcutaneous injection. The dosage and frequency will be determined by the study protocol. This medication is part of your treatment plan alongside your chemotherapy regimen.
Step 4
Chemotherapy cycles
You will undergo several cycles of chemotherapy. Before each cycle, specific biomarkers, including CA-125, will be measured to monitor your response to the treatment.
Step 5
Monitoring and follow-up
Throughout the trial, your health will be closely monitored. Blood tests will be conducted to measure levels of hemoglobin, platelets, and other markers. You will also be evaluated for any side effects from the medication.
Step 6
Post-treatment evaluation
After completing the chemotherapy cycles, a final evaluation will be conducted. This includes measuring the levels of CA-125 and other biomarkers three weeks after the last cycle.
Step 7
End of participation
Your participation in the study will conclude after the final evaluation. You will receive information about the results and any further steps if necessary.

Who can join the trial?

9 criteria

Must have **epithelial ovarian cancer**, **fallopian tube cancer**, **peritoneal cancer**, or **abdominal cancer** that started in the ovary, fallopian tube, or peritoneum.
Must have a **histology diagnosis** (a test that looks at tissue under a microscope) of either **high grade serous carcinoma**, **endometroid carcinoma**, or **clear cell carcinoma**.
Must have **FIGO stage III-IV disease**, which means the cancer is in an advanced stage.
Must be planned for a **platinum doublet regimen**, a type of chemotherapy treatment.
Must have a **WHO Performance Status** of 0-1, which means the patient is fully active or has some symptoms but does not need bed rest.
Must have a **CA-125 level** of 250 kIE/L or higher at diagnosis. CA-125 is a protein that can be a marker for ovarian cancer.
Must weigh between 50 and 150 kg.
Must be aged 18 or older.
Must be female.

Who cannot join the trial?

4 criteria

Patients who do not have epithelial ovarian cancer cannot participate. This is a type of cancer that starts in the cells on the surface of the ovary.
Only female patients can participate. Male patients are not eligible.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population are not eligible. This means groups of people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
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Region Oestergoetland
Linkoping, Sweden
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Region Vaesterbotten
Umea, Sweden

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Investigated drugs

Tinzaparin is a medication used in this clinical trial. It is a type of blood thinner, which means it helps prevent blood clots from forming in your body. In this study, tinzaparin is being tested to see how it affects certain markers in the blood of patients with advanced ovarian cancer who are receiving chemotherapy before surgery. The goal is to understand if tinzaparin can influence these markers, which might help in managing the disease better.

Tinzaparin Sodium

What is already known about the treatment

Tinzaparin – Tinzaparin is administered as an injection under the skin, typically in the abdomen or thigh. It is currently being studied in clinical trials for its effects on biomarkers in patients with advanced ovarian cancer undergoing chemotherapy. The main therapeutic use of tinzaparin in this context is to evaluate its impact on the levels of a specific cancer marker called CA-125. At the molecular level, tinzaparin works by inhibiting certain proteins involved in blood clotting, which may also influence cancer progression. It is classified as a low molecular weight heparin, a type of anticoagulant medication.

Investigated diseases

Epithelial ovarian cancer – Epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. It is the most common form of ovarian cancer and primarily affects women after menopause. The disease often progresses silently, with symptoms appearing only in advanced stages. As it advances, it can spread to the pelvis, abdomen, and other parts of the body. The progression involves the growth of cancerous cells that can form tumors and potentially invade nearby tissues. Over time, it may lead to the accumulation of fluid in the abdomen, known as ascites, and can affect the function of nearby organs.