Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

BIOMarkers in Endometrial Cancer - A phase III open label randomized trial to determine the efficacy of biomarker staging as compared to conventional staging in women with presumed early-stage endometrial cancer (The BIOMEC trial)

The BIOMEC study is a research trial for women diagnosed with early-stage womb cancer, also known as endometrial cancer. The main goal is to compare two different ways doctors assess how much the cancer has spread. One way is the usual method, and the other involves looking at special markers in the body. Researchers want to find out if using these markers can lead to better outcomes for patients, specifically helping them live longer. The study might also look at how these methods affect a patient's quality of life and if they experience fewer cancer recurrences. Sometimes, the study might involve common chemotherapy drugs like paclitaxel and carboplatin.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Karolinska University Hospital

Enrolment target

1,037

Start

29 Sep 2023

ENDOMETRIAL CANCER

What is this study about?

The BIOMEC study is a significant clinical trial focusing on endometrial cancer, which is cancer that starts in the lining of the womb. When you're diagnosed with early-stage endometrial cancer, doctors need to understand how far it has spread to plan the best treatment. This study is designed to compare two different ways of checking for cancer spread. One way is the current standard approach, which doctors have been using for a while. The other method involves looking at 'biomarkers' – these are like special signs in your body that can give clues about the cancer.

The main reason for this study is to see if using these biomarker tests can lead to better overall survival for women with early-stage endometrial cancer. This means finding out if patients who have their cancer assessed using biomarkers live longer than those whose cancer is assessed using the standard methods. Understanding the cancer's spread more accurately could help doctors tailor treatments more effectively.

Beyond just surviving longer, the study also looks at other important aspects of a patient's health and well-being. For example, it will check how often the cancer comes back, a measure called 'recurrence-free survival.' It will also closely monitor patients' quality of life using questionnaires, look at their physical ability and frailty, and gather information on side effects or complications from treatments. This comprehensive approach ensures that if a new method proves better, it's not just about lifespan but also about ensuring a good quality of life.

Key takeaways

The BIOMEC study investigates better ways to stage early-stage womb cancer.
It compares standard staging with a new method using 'biomarkers'.
The main goal is to see if biomarker staging helps women live longer.
The study also examines quality of life and cancer recurrence.
Participation might involve common chemotherapy drugs like paclitaxel and carboplatin.
You must be an adult woman with early-stage womb cancer to take part.

Who may be eligible?

This study is specifically designed for women who have been diagnosed with early-stage endometrial cancer, which is cancer of the womb lining. To take part, you need to be at least 18 years old; there's no upper age limit. It's open only to women.

Before joining, doctors will carefully check your medical history and conduct tests to make sure the study is right for you. They will confirm that your cancer is considered early-stage, as the study focuses on this particular group of patients.

It's important that your general health allows you to safely participate in the study, including potentially receiving treatments like chemotherapy if that's part of the study plan. Your medical team will discuss all of these points with you to determine if you meet all the criteria.

Quick self-check

Are you a woman?
Are you 18 years old or older?
Have you been diagnosed with early-stage womb (endometrial) cancer?
Are you able to attend regular hospital visits and tests?
Are you willing to potentially receive chemotherapy if assigned to that group?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the BIOMEC study, you would first have a full assessment to confirm you meet all the requirements. You would then be randomly assigned to one of two groups: one receiving standard cancer staging or another receiving staging based on biomarkers. This is like flipping a coin, so it's fair. The study might involve receiving chemotherapy drugs, paclitaxel and carboplatin, depending on your assigned group and treatment plan.

You would have regular appointments and tests throughout the study to monitor your health, how the cancer is responding, and to check for any side effects. This includes detailed scans, blood tests, and filling out questionnaires about your quality of life. After your initial treatment period, there will be a follow-up period to keep track of your health long-term. The total duration of your active participation and follow-up will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving state-of-the-art care and close monitoring by medical experts, and contributing to medical knowledge that could help future patients. However, there are also potential risks, including side effects from treatments like chemotherapy (e.g., hair loss, nausea, fatigue), potential complications from procedures, or that the new approach may not be better than standard care. You might also need more hospital visits or tests than usual. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Sweden

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's one of the most common gynaecological cancers.

What are biomarkers?

Biomarkers are special signs or substances in the body that can give clues about a disease, like cancer. In this study, they help understand how much the cancer has spread.

What is 'early-stage' cancer?

'Early-stage' cancer means the cancer is found only in the womb or has not spread far. It's often easier to treat at this stage.

Will I definitely receive chemotherapy?

Whether you receive chemotherapy depends on many factors, including which study group you are in and your specific cancer details. The study aims to compare different approaches, and chemotherapy might be part of one approach.

Can I choose which treatment group I'm in?

No, you cannot choose. Participants are randomly assigned to a group, like flipping a coin. This helps ensure the study results are fair and unbiased.