CompletedInterventional

ROCkeTS: Refining Ovarian Cancer Test Accuracy Scores

The ROCkeTS trial is a UK health study designed to improve how doctors check for ovarian cancer. At the moment, diagnosing ovarian cancer can be tricky because symptoms like bloating and tummy pain are common in many harmless conditions. This study tests a new system that combines special blood markers with ultrasound scans. By putting these results together, doctors hope to create a clearer, more accurate risk score. The study is for women who have possible symptoms of ovarian cancer and have already had an abnormal scan or a raised result on a routine CA125 blood test. Taking part does not change your planned medical care. Instead, it allows researchers to check whether this new scoring system works better than the tools used today. The ultimate goal is faster, more accurate diagnosis and fewer unnecessary operations.

At a glance

Status

Completed

Sponsor

University of Birmingham

Enrolment target

2,450

Start

05 Jun 2015

Estimated completion

31 Mar 2023

Topic: Cancer; Subtopic: Gynaecological Cancer; Disease: Ovary/Fallopian tube

What is this study about?

Ovarian cancer can be difficult to spot early because its warning signs, such as feeling full quickly, tummy pain, and bloating, are very common. Doctors currently use ultrasound scans and a blood test called CA125 to check for problems. However, these tests are not always completely accurate, which can sometimes lead to delays or mean women undergo worry and surgery they did not actually need.

The ROCkeTS study aims to solve this problem. Researchers are developing and testing a new scoring tool that combines ultrasound images with specific blood markers. By carefully analysing these results together, the tool tries to give doctors a much clearer picture of whether a person has ovarian cancer or a harmless condition.

This research is important because catching cancer early makes it much easier to treat. At the same time, giving women with non-cancerous conditions quick reassurance protects them from unnecessary stress and invasive procedures. By joining the study, participants help researchers build a better, kinder diagnostic process for women in the future.

Key takeaways

The ROCkeTS study tests a new way to combine scans and blood tests to diagnose ovarian cancer.
It aims to make diagnosis faster and reduce unnecessary surgery for benign conditions.
Participation involves blood samples and an internal ultrasound scan alongside your normal appointments.
The study does not involve new drugs or alter your standard NHS care.
You are free to leave the trial at any time without your care being affected.

Who may be eligible?

This study is open to women who have possible symptoms of ovarian cancer, whether they have gone through the menopause or not. To be considered, you must have either a higher-than-normal result on a CA125 blood test, or an ultrasound scan showing an unusual change in your ovaries or fallopian tubes.

You will not be able to take part if your ultrasound shows that your symptoms are caused by something clearly not linked to ovarian cancer, such as common womb fibroids or small, simple fluid cysts under 5 centimetres across. You also cannot take part if your pelvic scan looks completely normal.

Additionally, joining requires having an internal scan (a transvaginal ultrasound). If you are unable to have this scan, or if you prefer not to have one, you will not be able to join the study. You must also be able to understand the study information and give your consent to join.

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.

I am a woman with symptoms that could be linked to ovarian cancer.
I have had a high CA125 blood test result OR an abnormal pelvic ultrasound scan.
I am willing and able to have an internal (transvaginal) ultrasound scan.
I do not have a scan showing only simple, harmless cysts smaller than 5cm or fibroids.
I am able to give fully informed consent to take part.

Answer every question to see your result.

What does participation involve?

Taking part in ROCkeTS is designed to fit alongside your normal NHS hospital appointments. You will not need to take any experimental medicines or stop your routine treatment. When you attend your usual clinic, the research team will ask to take extra blood samples and carry out a detailed pelvic ultrasound, including an internal scan through the vagina. You will also be asked some questions about your symptoms and health history. The team will follow your progress through your regular medical records over the course of your care to see how accurate the new tests were compared to your final diagnosis.

Potential risks and benefits

Taking part in this study may not directly change your own diagnosis or treatment, but the information collected will help improve testing for many women in the future. The physical risks are very low. An internal ultrasound can sometimes feel slightly uncomfortable, and having blood taken may cause temporary bruising or minor soreness. Your usual medical care will continue as normal throughout, and choosing to take part is entirely voluntary. You have the right to withdraw from the study at any point without it affecting your medical care in any way.

Locations (1)

University of Birmingham
Approximate
Birmingham, England

Common questions

Will taking part change the medical treatment I receive?

No. You will continue to receive your usual NHS care and treatment. The study simply collects test results and scans to see how accurate the new scoring system is.

What is an internal (transvaginal) ultrasound?

This is a standard scan where a small, smooth probe is gently placed into the vagina. It gives doctors a very close, clear picture of your ovaries and womb.

Does having a high CA125 test mean I have cancer?

Not necessarily. CA125 is a protein in the blood that can rise with ovarian cancer, but it also goes up due to common conditions like endometriosis, fibroids, or infections.

Do I have to pay for anything to take part?

No, taking part is free, and the tests are done during your regular visits within the NHS.

Can I leave the study if I change my mind?

Yes, you can leave at any time. You do not need to give a reason, and your medical team will continue to look after you just as before.

How to find out more

Ryan Ottridge

r.ottridge@bham.ac.uk +44 121 415 9127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.