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.

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 refers to a specific alteration in the isocitrate dehydrogenase 1 (IDH1) that affects how cells produce energy and function. This mutation can lead to the buildup 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 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 which 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 is a “sugar pill” that resembles medication, or a product being tested but has no treatment value. Clinical trial participants may receive a placebo to compare results on the risks and benefits of a medication and learn from their differences.

Randomization 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.

Blinded studies are designed to prevent members of the research team and clinical trial participants from influencing the results by not knowing if the patient is receiving placebo or treatment.

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 what you are given. Members of the research team are not told which participants are receiving which treatment to reduce bias. If it becomes medically necessary, however, it is always possible to find out which treatment you are receiving.

In a blind study, all participants are monitored to determine if the medication or product being studied is safe and effective. If participants in this particular clinical trial who are being monitored show that the chondrosarcoma is getting worse on the radiographic images, the researchers will unblind the study to determine if you received the medication or a placebo. If you received a 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 really worsens or in case 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.

If you have additional questions about taking part in this study, you can share this website with your doctor to discuss the CHONQUER study.