सभी अध्ययन
भर्तीNAहस्तक्षेपात्मक

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

This study is for people with desmoid tumours that have started to grow or cause symptoms after a period of watchful waiting. Usually, if your tumour grows, you might be given medication, like chemotherapy. This study compares that medical treatment with a procedure called cryoablation, which uses extreme cold to destroy the tumour. Researchers want to find out which treatment is more effective for these types of growing tumours. Patients in the study might get one treatment first, and if needed, they could switch to the other. This helps make sure everyone has access to cryoablation if it's the right choice for them.

एक नजर में

स्थिति
भर्ती
चरण
NA
प्रायोजक
University Hospital, Strasbourg, France
नामांकन लक्ष्य
150
प्रारंभ
04 मार्च 2024
अनुमानित पूर्णता
01 जून 2029

यह अध्ययन किस बारे में है?

When someone is first diagnosed with a desmoid tumour, doctors often suggest a 'wait and see' approach. This means they monitor the tumour closely to see if it grows or causes problems, rather than treating it straight away. If the tumour does start to grow or causes symptoms, doctors usually recommend medicines, which can include certain types of chemotherapy.

This study, however, is looking into another treatment option called cryoablation. This procedure uses very cold temperatures to freeze and destroy the tumour. Cryoablation has already shown promise in treating larger desmoid tumours that are growing or causing symptoms. The main goal of this study is to compare cryoablation with the usual medical treatments to see which is more effective when a desmoid tumour starts to progress after the initial 'wait and see' period.

Being part of this study means you would be randomly assigned to either receive cryoablation or medical therapy. The good news is that the study design allows for a 'cross-over'. This means if the first treatment isn't working as well as hoped, or if it becomes necessary, you might be able to switch to the other treatment. This ensures that all patients potentially benefit from cryoablation if it's found to be helpful.

मुख्य निष्कर्ष

  • Compares freezing tumours (cryoablation) with medicine.
  • For desmoid tumours growing after 'wait and see'.
  • Patients aged 13 and older can take part.
  • Opportunity to receive cryoablation if it's the right choice.
  • Close monitoring of your tumour's progress.

कौन पात्र हो सकता है?

This study is looking for volunteers who are at least 13 years old and have a desmoid tumour that is not inside the tummy area (extra-peritoneal). We need to have a clear diagnosis of your tumour from a recent biopsy.

Your tumour must have started to grow or cause more symptoms after a period where doctors were just watching it. It also needs to be easily reached by the special tools used for cryoablation, and the doctors must be confident they can remove 100% of it using this method, even if it takes more than one try. You should also be generally well, able to carry out your normal daily activities, and have healthy blood test results.

क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?

यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.

  1. Are you 13 years old or older?
  2. Do you have a desmoid tumour not in your tummy area?
  3. Has your tumour grown or caused more symptoms recently?
  4. Is your tumour in a place where it can be frozen safely?
  5. Are your general health and blood tests good?
अपने परिणाम देखने के लिए हर प्रश्न का उत्तर दें।.

भागीदारी में क्या शामिल है?

The specific details of your participation, such as how many visits you'll need, what assessments will be done, and the total duration, are not fully described in this summary. However, you would be randomly assigned to either receive cryoablation or medical therapy. Cryoablation is a procedure, so it would involve appointments for the treatment itself. Medical therapy would involve taking medication, likely with regular check-ups to monitor its effects. There would be imaging scans, like MRI, to keep track of your tumour's size and to see how well the treatment is working. You will have regular checks of your health and blood tests. You'll need to use reliable contraception if you're a woman who could become pregnant. The study aims to follow your progress and the effect of the treatment over time.

संभावित जोखिम और लाभ

Taking part in this study may offer potential benefits, such as access to cryoablation, which has shown promise for certain desmoid tumours, or receiving standard medical therapy under close monitoring. However, there are also potential risks associated with any medical treatment, including side effects from medication or complications from the cryoablation procedure. The study team will explain these risks in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

स्थान (13)

  • Service d'oncologie/CHU de Besançon
    सत्यापित पोस्टकोड
    बेसनसों, फ्रांस· अभी भर्ती नहीं हो रही है
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIE
    सत्यापित पोस्टकोड
    बोर्दो, फ्रांस· भर्ती
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSE
    सत्यापित पोस्टकोड
    काँ, फ्रांस· भर्ती
  • Service d'Oncologie Médicale -Centre Georges François LECLERC
    सत्यापित पोस्टकोड
    डिजॉन, फ्रांस· भर्ती
  • Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARD
    सत्यापित पोस्टकोड
    ल्यों, फ्रांस· भर्ती
  • Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timone
    सत्यापित पोस्टकोड
    मार्से, फ्रांस· भर्ती
  • Service de Radiologie-CHU de Nantes
    सत्यापित पोस्टकोड
    नांत, फ्रांस· भर्ती
  • Service d'Oncologie Médicale-Centre Antoine LACASSAGNE
    सत्यापित पोस्टकोड
    नाइस, फ्रांस· भर्ती
  • Service d'Oncologie Médicale
    सत्यापित पोस्टकोड
    Saint-Herblain, France· भर्ती
  • Institut de cancérologie Strasbourg Europe (ICANS)
    सत्यापित पोस्टकोड
    स्ट्रासबर्ग, फ्रांस· भर्ती
  • Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091
    सत्यापित पोस्टकोड
    स्ट्रासबर्ग, फ्रांस· भर्ती
  • Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouse
    सत्यापित पोस्टकोड
    टूलूज़, फ्रांस· अभी भर्ती नहीं हो रही है

सामान्य प्रश्न

What is a desmoid tumour?

It's a rare type of growth that is not cancer but can grow into nearby tissues and sometimes causes pain or problems.

What is 'watchful waiting'?

This means doctors will carefully monitor your tumour to see if it changes or grows before suggesting active treatment.

What is cryoablation?

It's a procedure that uses very cold temperatures to freeze and destroy the tumour.

Will I definitely get cryoablation in this study?

You might get cryoablation or medical therapy. The study design allows you to switch to cryoablation later if needed.

Can children join this study?

Yes, individuals aged 13 and older can take part if they meet the other study requirements.

और अधिक जानने के लिए कैसे पता करें

Afshin GANGI, MD,PhD

किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.

भाग लेने में रुचि रखते हैं?

अपनी रुचि दर्ज करें

अपने विवरण साझा करें और अनुसंधान टीम के लिए "Cryoablation Versus Medical Therapy in Desmoid Tumors Progre…यदि आप पात्र हो सकते हैं तो आपसे संपर्क करेंगे। भाग लेने के लिए सहमति देने से पहले हमेशा अपने जीपी से बात करें।.

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