Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
This study is investigating whether a medication, called thromboprophylaxis, can prevent serious blood clots in men with advanced germ cell cancer. These men are receiving their first round of chemotherapy, which uses a drug called cisplatin. Some patients with a higher risk of blood clots will be randomly assigned to either receive the preventive medicine or not, so researchers can compare the two groups. Other patients with a lower risk will not receive the medicine but will still be part of the study. The study will last for about 14 to 17 weeks, depending on how many cycles of chemotherapy are planned. The goal is to see if this preventive medicine can significantly lower the number of people who develop a blood clot.
At a glance
What is this study about?
Imagine your blood is normally a liquid, flowing freely around your body. Sometimes, it can thicken and form a clump, or a 'clot'. While some clots are good – for example, to stop bleeding when you cut yourself – others can be dangerous if they form inside your blood vessels when they shouldn't. These dangerous clots can block blood flow and cause serious health problems, such as a deep vein thrombosis (DVT) in your leg, or a pulmonary embolism (PE) if the clot travels to your lungs.
People with advanced cancer, especially those undergoing chemotherapy, can sometimes have a higher chance of developing these dangerous blood clots. This study is focusing on men who have a specific type of cancer called germ cell tumour, which is a type of cancer that usually starts in the reproductive organs. They are receiving their first treatment of chemotherapy that includes a drug called cisplatin.
Researchers want to find out if giving a special blood-thinning medicine, called thromboprophylaxis, can help prevent these clots from forming. They will compare a group of high-risk patients who receive this preventative medicine with another group who don't. The aim is to see if the medicine can make a real difference in preventing blood clots and keeping patients safer during their cancer treatment.
Key takeaways
- This study investigates a medicine to prevent blood clots in men with advanced germ cell cancer.
- Participants will undergo first-time cisplatin-based chemotherapy.
- Higher-risk patients will be randomly assigned to either receive the preventative medicine or not.
- The study lasts about 14-17 weeks.
- The goal is to reduce the chance of serious blood clots by 12% in the high-risk group.
Who may be eligible?
To join this study, you need to be a man over 18 years old who has been diagnosed with a germ cell tumour that has responded well to treatment in the past, or has a moderate outlook. You must be suitable for a specific type of first-time chemotherapy that uses the drug cisplatin, and you shouldn't have had any other chemotherapy before.
If you're considered to be at a higher risk of developing blood clots, you might be asked to join the main part of the study where we compare two groups. This higher risk could be due to factors like certain levels of a substance in your blood (called lactate dehydrogenase), your body size, or the size of any lymph nodes in your abdomen. You'd also need to be able to understand and sign the consent forms and be willing to come to all the study appointments.
However, you wouldn't be able to join if you have cancer that has spread to your brain, a history of blood clots, or if you're already taking blood-thinning medicines. Other reasons you might not be able to join include kidney problems, if you've recently had major surgery, have very high blood pressure, or a low number of blood cells called platelets. Also, if you have a high risk of bleeding, you would not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man over 18 years old?
- Do you have a germ cell tumour (good or intermediate outlook)?
- Are you about to start your first course of cisplatin-based chemotherapy?
- Do you have no history of dangerous blood clots?
- Are you NOT currently taking blood-thinning medication?
- Can you attend regular appointments and follow study instructions?
What does participation involve?
If you decide to take part, you would be involved in the study for about 14 to 17 weeks. This period depends on how many cycles of chemotherapy your doctor plans for you. During this time, the researchers will carefully monitor your health. If you are in the high-risk group, you would either receive the blood clot prevention medicine or not, depending on which group you are randomly assigned to. You would have regular visits and assessments, which would likely include blood tests and physical examinations to check on your health and any side effects. You'll need to follow the study's instructions carefully and attend all scheduled appointments.
Potential risks and benefits
Locations (26)
- ICO Paul PapinVerified postcodeAngers, France· Recruiting
- CH de la Côte BasqueVerified postcodeBayonne, France· Recruiting
- Institut BergoniéVerified postcodeBordeaux, France· Not yet recruiting
- CHU de BrestVerified postcodeBrest, France· Not yet recruiting
- CHU de Clermont-FerrandVerified postcodeClermont-Ferrand, France· Recruiting
- Groupe Hospitalier Mutualiste de GrenobleVerified postcodeGrenoble, France· Not yet recruiting
- Centre Oscar LambretVerified postcodeLille, France· Recruiting
- CHU de LimogesVerified postcodeLimoges, France· Recruiting
- Centre Léon BérardVerified postcodeLyon, France· Recruiting
- Institut Paoli-CalmettesVerified postcodeMarseille, France· Not yet recruiting
- Centre Antoine LacassagneVerified postcodeNice, France· Recruiting
- Hôpital Saint LouisVerified postcodeParis, France· Recruiting
Common questions
What is a 'germ cell tumour'?
A germ cell tumour is a type of cancer that usually starts in the cells that would normally develop into sperm or eggs. It can occur in different parts of the body.
What does 'thromboprophylaxis' mean?
Thromboprophylaxis is a medical term for treatments or medicines used to prevent blood clots from forming, often called blood thinners.
Why is this study only for men?
Germ cell tumours can affect both men and women, but this particular study is focusing on men with a specific type and stage of the cancer.
What is 'cisplatin-based chemotherapy'?
Cisplatin is a strong anti-cancer drug. 'Cisplatin-based chemotherapy' means your treatment plan includes this drug, often with others, to kill cancer cells.
What are 'blood clots' and why are they dangerous?
Blood clots are clumps of blood that can block blood vessels. They are dangerous if they form where they shouldn't, as they can cause serious problems like a heart attack, stroke, or damage to your lungs or legs.
How to find out more
Ophélie LION
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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