Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study
This study, called IDHIRA, is observing how a new medication called ivosidenib works for people in Germany with a rare and serious type of cancer called cholangiocarcinoma, which affects the bile ducts. This particular cancer must have a specific genetic change, known as an IDH1 R132 mutation. Participants must have already tried at least one other treatment. Ivosidenib was approved in May 2023 for this condition. The study is simply watching how the drug is used in real life, collecting information on how effective it is, how it affects patients' quality of life, and any side effects. It's not a trial where different treatments are tested against each other, but rather an observation of an already approved treatment.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Cholangiocarcinoma is a rare but serious cancer that starts in the bile ducts, which are tubes that carry digestive fluid (bile) from the liver. Unfortunately, treatments for this type of cancer have been quite limited, and the outlook for patients can be challenging.
Recently, a new medication called ivosidenib has been approved for some patients with this cancer. This drug is special because it targets a specific genetic change in the cancer cells, known as an IDH1 R132 mutation. Not all cholangiocarcinomas have this change, so it's a treatment option for a specific group of patients who have this particular mutation and who have already tried at least one other treatment.
This study, called IDHIRA, is an "observational study." This means that doctors are simply watching and collecting information about how ivosidenib is being used by patients in Germany in their day-to-day care. They want to see how well the treatment works in a variety of patients, how it affects their quality of life, and if there are any side effects. This type of study helps doctors understand how new treatments perform in the real world, outside of strict clinical trial settings.
النقاط الرئيسية
- The study is observing how an approved drug, ivosidenib, works for bile duct cancer.
- It focuses on patients with a specific genetic change in their cancer (IDH1 R132 mutation).
- Participants must have already tried at least one other cancer treatment.
- The study aims to understand the drug's effectiveness, safety, and impact on quality of life in a real-world setting.
- You would receive ivosidenib as part of your normal care; no experimental treatments are involved.
من قد يكون مؤهلاً؟
To be considered for this study, you must be 18 years old or older and have cholangiocarcinoma (bile duct cancer) that has spread or is advanced. It's very important that your cancer has a specific genetic change called an IDH1 R132 mutation, which must have been found through a medical test. You also need to have already received at least one other treatment for your cancer.
Your doctor must have decided that ivosidenib is the right treatment for you based on current medical guidelines. If you choose to take part, you'll need to sign a consent form. If you also decide to take part in the optional part of the study that looks at your quality of life, you'll need to sign that consent before starting the treatment and be able to complete assessments in German.
You cannot join this study if you are already taking part in another clinical trial where you are receiving a specific treatment, or if you have any other medical conditions that would prevent you from safely taking ivosidenib, according to your doctor's assessment.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك 18 سنة أو أكثر؟
- Do you have advanced or metastatic bile duct cancer (cholangiocarcinoma)?
- Has your cancer been tested and confirmed to have an IDH1 R132 mutation?
- Have you already received at least one other treatment for your cancer?
- Has your doctor decided that ivosidenib is a suitable treatment for you?
ماذا يتضمن المشاركة؟
This is an observational study, which means no new treatments are being given. You would receive ivosidenib as part of your standard medical care, just as your doctor would prescribe it outside of the study. The study involves your medical team collecting information about how you respond to ivosidenib, any side effects you experience, and how the treatment affects your overall well-being. This information would be gathered from your regular hospital visits and check-ups. There might be an optional part of the study where you would be asked to answer questions about your quality of life. The total duration of your participation would depend on how long your doctor determines you need to be on ivosidenib.
المخاطر والفوائد المحتملة
المواقع (7)
- Hämatologisch-Onkologische Schwerpunktpraxis in Bad Liebenwerdaالرمز البريدي المؤكدBad Liebenwerda, Germany· التوظيف
- Caritas Krankenhaus Bad Mergentheimالرمز البريدي المؤكدBad Mergentheim, Germany· التوظيف
- Onkologisches Versorgungszentrum Berlin MVZالرمز البريدي المؤكدبرلين، ألمانيا· التوظيف
- Onkologie Hannoverالرمز البريدي المؤكدهانوفر، ألمانيا· التوظيف
- Onkologie Hofالرمز البريدي المؤكدHof, Germany· التوظيف
- Medizinisches Versorgungszentrum Mönchengladbachالرمز البريدي المؤكدمونشنغلادباخ، ألمانيا· التوظيف
- ze:roPRAXEN MVZ für Innere Medizinالرمز البريدي المؤكدWeinheim, Germany· التوظيف
أسئلة شائعة
What is cholangiocarcinoma?
It's a rare type of cancer that starts in the bile ducts, which are small tubes in your liver that carry digestive fluid.
What is an IDH1 R132 mutation?
It's a specific genetic change found in some cancer cells. Ivosidenib targets this particular change.
Is ivosidenib a new drug?
Yes, it was recently approved by the European Medicines Agency in May 2023 for this specific type of bile duct cancer.
Will I get unique treatment by joining this study?
No, you will receive ivosidenib just as your doctor would normally prescribe it. The study just gathers information about your treatment experience.
ماذا يعني "دراسة رصدية"؟
It means doctors are watching and collecting information about an existing treatment in real-life patients, rather than trying out new treatments or comparing different ones.
كيفية معرفة المزيد
Sina Grebhardt, PhD
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
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نقاش
مناقشة المجتمع
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