FAQs

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect or treat disease. Clinical trials can study: new drugs or new combinations of drugs. They are tightly regulated with specific criteria for gathering data and, most importantly, protect the patient participating in the clinical trial.  

As a participant in a clinical trial, your care and treatment are carefully monitored and controlled. The medical team conducting the trial will inform you about every possible outcome and they’ll explain everything that is occurring. Finally, you are free to stop the trial at any time. You can request information about clinical trials, and presuming you meet the trial criteria, you can participate in a clinical trial at any point in your cancer journey.  

A clinical trial is led by a principal investigator (PI). Members of the research team regularly monitor the participants’ health through testing to determine the study’s safety and effectiveness. Participating in a clinical trial may take more time than standard treatment, and you may have more tests and treatments than you would if you were not participating in a clinical trial. The study team also may ask you to keep a log of symptoms or other health measures, fill out forms about how you feel, or complete other tasks. You may also need to travel to take part in a study. 

The IDH1 gene mutation leads to a specific alteration in a protein called isocitrate dehydrogenase 1 (IDH1) that affects how cells produce energy and function. This mutation can lead to the build-up of a substance called D-2-hydroxyglutarate (2-HG), which interferes with normal cell function, including DNA repair and gene regulation. This disruption can contribute to cancer development and progression. Approximately 50% of conventional chondrosarcomas have an IDH1 mutation.

For people with a type of chondrosarcoma known as ‘conventional chondrosarcoma’, having an IDH1 mutation may make them eligible for the CHONQUER study. This clinical trial is assessing an investigational treatment targeting the IDH1 mutation, offering a potential option for managing this condition.

The purpose of regular medical care is to improve or otherwise manage your health. A clinical study does not replace your regular medical care. Its purpose is to gather information to advance science and discover new treatments.

Each clinical trial defines who is eligible to take part in the study. The protocol outlines the factors that include or exclude a potential participant. The study must include only people who match the required characteristics of participants for that study.

Clinical trials compare a new medication, new product or new procedure with another that already exists. In these types of studies, you may be assigned to receive a  placebo. A placebo resembles the study medicine but doesn’t have any active ingredients in it. Clinical trial participants may receive a placebo so researchers can compare results on the risks and benefits of a medication and learn from their differences.

Randomisation in clinical trials means that each participant has an equal chance of being in any of the groups of the trial (for example, a group receiving the study medicine or a group receiving the placebo). It is an important method to reduce the risk of bias in the outcomes of the trial. 

The design of blinded studies, in which it is not known if the patient is receiving placebo or study drug, ensures that the results of the study are not influenced by the research team or clinical trial participants. 

In a single-blind study, you are not told what is being given, but the research team knows.

In a double-blind study, neither you nor the research team are told which treatment you are given. Members of the research team are not told which treatment participants are receiving as this is a means of reducing bias. If it becomes medically necessary, however, it is always possible to find out which treatment you are receiving.

In a blinded study, all participants are monitored to determine if the medication or product being studied is safe and effective. If the radiographic images show that the chondrosarcoma is getting worse in the participants who are being monitored in this particular clinical trial, the researchers will unblind the study to determine if the participants received the medication or the placebo. If you received the placebo, you would have the option to take the medication being studied and continue with the trial. If you were on the medication itself, the investigator will determine if you could still benefit by continuing the study treatment or not.  

Informed consent is the process of providing you with all the key information about a research study before you decide whether to accept the offer to participate.  

It is very important that you fully understand the terms, conditions, risks and benefits.

Taking part in a clinical trial is voluntary and you can leave the study at any time. To participate, it will be necessary for you to sign an informed consent document. To help you decide whether to take part in the clinical trial, the staff of the research team are responsible for explaining all the details of the study and making sure you understand the research process as well as the terms and conditions of the study.

The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains the risks and potential benefits. Once you understand all the conditions included in the document, you can then decide whether to participate and sign the document.

The length of a clinical study can vary, but the CHONQUER study lasts until your disease worsens or too many side effects are encountered. Prior to being included in this study, there is a period where your doctor will assess if all conditions needed to be included are met. If you join, you will take the study medication (or placebo) daily and attend regular check-ups to monitor your health. After treatment, follow-up visits will check your progress. Taking part in a clinical study is entirely voluntary (your choice) and you can leave at any time without explanation or any negative impact on your regular healthcare. Additionally, the study team may stop your participation if needed for health or safety reasons.

'Conventional': 'Conventional' in general means something that is traditional, standard, or commonly used and accepted. In the video it is mentioned in the context of 'conventional chondrosarcoma'. Conventional chondrosarcoma is a type of cancer that starts in the cartilage, which is the tough, flexible tissue that helps cushion joints and supports various structures in the body. It is a cancer that forms in the cartilage cells. This type of cancer typically grows slowly and can cause pain and swelling in the affected area. It's most commonly found in the bones of the arms, legs and pelvis.

'Mutation':A 'mutation' is a change or alteration in the DNA of a cell. DNA is like a set of instructions that tells cells how to function and grow. In simpler terms, a mutation is like a typo or mistake in these instructions.

'Experimental treatment':'Experimental treatment' refers to a new medical approach or therapy that is still being tested and studied in a specific disease setting to understand how well it works and how safe it is. It is a treatment that doctors and researchers are trying out to see if it can help patients, but it hasn't yet been fully approved for regular use.

'Curative surgery': An operation that aims to completely remove or fix a problem in the body, with the goal of curing the patient.

'Oral tablets':Medicines that are taken by mouth and swallowed.

'Imaging scans':These are special kinds of photographs that doctors use to see what's happening inside your body without having to do surgery. Common types of imaging scans include X-rays, CT scans, MRI scans and ultrasounds. These pictures help doctors diagnose and monitor medical conditions by showing them detailed images of bones, organs and tissues.

Explanation of the mode of action of the IMP: The experimental treatment works by blocking the activity of the altered IDH1 enzymes. By doing so, it is expected to reduce the substance called D-2-hydroxyglutarate (2-HG). This is the substance that prevents cells from developing properly. By reducing the amount of 2-HG levels, it is expected to restore the normal activity in the cells.

If you are diagnosed with conventional chondrosarcoma and interested in taking part in the CHONQUER study and want to know if a clinical site is near you, visit our site finder.
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If you have questions about taking part in this study, you can share this website with your primary care doctor, General Practitioner or oncologist, to discuss whether this study is right for you.