RecruitingOBSERVATIONAL

CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1

This study, called CIRCULATE, is for people with certain types of oesophageal or stomach cancer that can be removed with surgery. Doctors want to find out if looking at special markers in the blood can help them understand the cancer better. They will collect blood samples from different body parts during surgery, and also over five years during follow-up appointments. The main idea is to see if these blood tests can show who might be at risk of the cancer spreading, and help doctors choose the most effective treatment plan, such as surgery alone or with other therapies. This research could lead to more personalised care for patients in the future.

At a glance

Status

Recruiting

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

100

Start

01 Feb 2021

Estimated completion

30 Jan 2028

Cancer of Esophagus Esophagogastric Junction Disorder

What is this study about?

This study is called CIRCULATE, and it's looking at new ways to understand oesophageal and a certain type of stomach cancer (called adenocarcinomas of the oesophagus and gastro-oesophageal junction). If you have one of these cancers and it can be removed with surgery, this study might be for you. The main goal is to see if we can find tiny bits of cancer information, called biomarkers, in your blood. These biomarkers could help doctors get a clearer picture of your cancer.

Imagine your body's blood system as a river. We want to see if we can find these cancer clues in different parts of this 'river' – like the blood flowing all around your body (peripheral veins) and also closer to the tumour (tumor-draining veins). The study also looks at other blood markers and fluid from your lymph system. By studying these, the doctors hope to work out if these markers can show who might be at a higher risk of their cancer spreading later on.

Ultimately, this research aims to help doctors make better and more personalised treatment decisions. This could mean knowing who would benefit most from surgery alone, or who might need extra treatments before or after surgery. This is an important step towards making sure each person gets the best possible care for their specific cancer.

Key takeaways

This study explores new blood tests for certain oesophageal and stomach cancers.
It aims to find better ways to choose the right treatment for each patient.
Participation involves giving extra blood samples during surgery and routine follow-up.
The study lasts for about five years, aligning with your standard care.
You won't receive direct benefit, but it could help future cancer patients.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to have been diagnosed with a specific type of cancer called adenocarcinoma, affecting the end of your oesophagus or the beginning of your stomach. Importantly, your cancer must be suitable for surgery, meaning it hasn't spread to other parts of your body in a way that makes surgery impossible.

Also, you need to be at least 18 years old and generally well enough to undergo surgery and follow-up care. Doctors will check your overall health using standard scores, like your ability to carry out daily activities and how healthy your body systems are for anaesthesia.

There are also some reasons why you wouldn't be able to join. For example, if your cancer is a different type (not adenocarcinoma), or if it's already spread too much for surgery to be an option. You also need to be able to understand the study and agree to take part.

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.

Do I have adenocarcinoma of the oesophagus or stomach (GEJ type I or II)?
Is my cancer currently suitable for surgery (not spread significantly)?
Am I 18 years old or older?
Am I generally well enough to undergo surgery and follow-up care?
Am I able to understand the study and willing to give consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for about five years. During your operation, doctors will collect some blood samples from different veins, including one near your tumour. If it's possible and safe during surgery, they might also collect a small amount of fluid from a lymphatic tube.

After your surgery, you won't need extra visits for the study itself. Instead, during your regular annual check-ups over the next five years, doctors will ask to take a blood sample. These samples will be used to see if the cancer markers change over time, and if they can predict whether the cancer might come back or spread. You'll continue with all your usual medical care as planned by your doctors, and these blood samples will be taken at those routine appointments.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could help doctors understand oesophageal and stomach cancer better, potentially leading to improved treatment for future patients. The main risks involve the extra blood samples taken, which are very safe but carry a small chance of bruising or discomfort. The sample from the lymphatic fluid is only collected if it can be done safely during surgery without extra procedures. You are always free to change your mind and withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (2)

University Hospital Cologne
Verified postcode
Cologne, Germany· Recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Not yet recruiting

Common questions

What is a 'biomarker'?

Biomarkers are like tiny clues in your body, often found in blood, that can tell doctors about your health or a disease like cancer.

Will taking part in this study change my treatment?

No, this is an observational study, meaning your treatment plan will be decided by your doctors based on current medical guidelines, not by the study results right now. The study aims to help future patients.

How much blood will be taken?

During surgery, about 60ml of blood will be taken. Then, at your annual check-ups for five years, about 20ml of blood will be taken each time.

Do I need extra hospital visits for the study?

No, all blood samples after surgery will be taken during your routine annual follow-up appointments, so you won't need extra trips.

What happens to the tissue collected?

Any tissue from your surgery not needed for your standard diagnosis will be safely stored in a special bank for future research, to help learn more about cancer.

How to find out more

Nikolas H Stoecklein, MD

nikolas.stoecklein@med.uni-duesseldorf.de 004921181 Official trial record

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