Active not recruitingOBSERVATIONAL

Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

This study aims to improve treatment for locally advanced cervical cancer. Current treatments, like radiotherapy and chemotherapy, don't always work for everyone, and some patients have ongoing side effects. We know that areas of low oxygen in tumours, called 'hypoxia', can make treatments less effective. If we can identify these areas accurately, we might be able to offer specific treatments that target them better. At the moment, there isn't a reliable way to check for hypoxia in cervical cancer patients before treatment. This project will explore both genetic information from tumour biopsies and detailed MRI scans. The goal is to find new ways to help doctors decide the best course of treatment for each individual, hopefully leading to more successful outcomes.

At a glance

Status

Active not recruiting

Sponsor

University of Manchester

Enrolment target

Start

10 Dec 2020

Estimated completion

31 Oct 2027

Cervical Cancer

What is this study about?

When someone has locally advanced cervical cancer, it means the cancer has grown into nearby areas but hasn't spread to distant parts of the body. The main treatments often involve radiotherapy, sometimes combined with chemotherapy. While these treatments are very important, unfortunately, they don't work for everyone, and occasionally patients can experience difficult side effects.

One of the main reasons treatments might not be as effective is something called 'hypoxia'. This is when parts of the tumour have very low levels of oxygen. Tumour cells in these low-oxygen areas can be harder to kill with radiotherapy. There are special treatments being developed that are designed to work better in these low-oxygen conditions. However, these treatments are most helpful for patients whose tumours actually have these hypoxic areas.

Currently, doctors don't have a simple, reliable test to figure out which cervical cancer patients have these low-oxygen areas in their tumours before starting treatment. This study is a chance to change that. We'll be looking carefully at information taken from small pieces of the tumour (biopsies) and also at detailed MRI scans. By studying these together, we hope to discover new clues, called 'biomarkers', that can help doctors understand each patient's tumour better and choose the most effective treatment plan, especially for those who might benefit from these special hypoxia-targeting therapies.

Key takeaways

The study aims to improve cervical cancer treatment by finding better ways to predict treatment success.
It focuses on 'hypoxia' (low oxygen in tumours), which can make radiotherapy less effective.
Participation involves providing tumour biopsies and having special MRI scans.
You will receive your standard cervical cancer treatment; no new drugs are involved.
The goal is to develop better 'biomarkers' to help doctors choose the most effective treatment for each patient in the future.
Your decision to join or leave the study won't affect your medical care.

Who may be eligible?

This study is for women aged 18 or over who have been diagnosed with cervical cancer that has grown locally. You'll need to have had a biopsy (a small tissue sample taken from the tumour) before starting treatment. It's important that you are generally healthy enough to receive the standard radiotherapy and other treatments normally given for cervical cancer.

There are certain reasons why someone might not be able to join the study. For example, if you have a medical device like a pacemaker or a hip replacement that would prevent you from having an MRI scan, or if you've had a bad reaction to the dye sometimes used in MRI scans. Also, if you have very severe kidney problems or other serious uncontrolled medical conditions, or if you are pregnant or breastfeeding, the study might not be suitable for you.

Your doctor will discuss all these points with you carefully to check if taking part in this study is safe and appropriate for your specific situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed diagnosis of cervical cancer?
Are you able to have standard radiotherapy and other usual treatments?
Do you have a biopsy (tissue sample) of your tumour available?
Are you able to have an MRI scan (e.g., no pacemaker or certain metal implants)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your usual treatment for cervical cancer, which includes radiotherapy and possibly chemotherapy. The study will involve a few extra steps.

You will have a small piece of your tumour taken, called a biopsy. This might be done before or during your radiotherapy. You will also have special MRI scans. These scans are a bit different from routine ones and are designed to give more detailed information about your tumour.

These additional tests are integrated into your normal treatment pathway. You won't be given any new experimental drugs or treatments as part of this study; it's focused on gathering more information to help future patient care. The total duration of your participation in the study will align with your standard treatment and follow-up, but the extra procedures would mostly happen around the time of your initial diagnosis and treatment.

Potential risks and benefits

Taking part in this study won't change your standard cervical cancer treatment. The main potential benefit is that the information we learn could help doctors in the future to better understand cervical cancer and tailor treatments more precisely for new patients. For you directly, there's no promise of personal benefit from the study procedures themselves, but you will be contributing to important medical research. Potential risks are generally linked to the procedures involved: biopsies can cause some discomfort, bleeding, or a small risk of infection, and MRI scans involve lying still in an enclosed space, and there's a very small risk of reaction to the contrast dye if used. Your safety and well-being are a top priority, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is a 'biomarker'?

A biomarker is like a clue from your body, such as something in your blood or a feature on a scan, that helps doctors understand what's happening with an illness or how well a treatment might work.

What does 'hypoxia' mean in a tumour?

Hypoxia means there are areas within the tumour that have very low oxygen. These low-oxygen areas can make some cancer treatments less effective.

Will I get a new experimental treatment if I join this study?

No, this study is not testing new treatments. You will receive the standard, normal treatment for your cervical cancer. The study is about collecting extra information to improve future care.

What is an MRI scan for this study?

An MRI scan uses magnets and radio waves to create detailed pictures inside your body. For this study, special types of MRI scans will be done to get more information about your tumour.

Can I stop being part of the study once I've started?

Yes, you can choose to stop participating in the study at any time, for any reason, and it will not affect the medical care you receive for your cancer.