RecruitingOBSERVATIONAL

Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods

This study, called ONCOSCREEN, is looking for better ways to detect bowel cancer early. Bowel cancer is common, but current screening methods like colonoscopies aren't always taken up by enough people, and stool tests can be tricky. This research wants to create new, simple, and affordable tests that are easy for patients to use at home. These new tests aim to be highly accurate and help catch bowel cancer, including early-onset cases, more effectively. The study will test several new diagnostic tools to see how well they work in people with bowel cancer and those at high risk.

At a glance

Status

Recruiting

Sponsor

Firalis SA

Enrolment target

4,100

Start

01 Aug 2024

Estimated completion

31 Dec 2026

Colorectal Cancer

What is this study about?

Bowel cancer (also known as colorectal cancer) is one of the most common cancers, affecting many people in the UK. Catching it early often means it's easier to treat. Currently, some common ways to check for bowel cancer are colonoscopies (where a camera looks inside your bowel) and stool tests (which check for hidden blood in your poo).

While these tests are important, some people find colonoscopies uncomfortable or are hesitant to have them. Stool tests can also be a bit inconvenient and sometimes miss early signs. Because of this, researchers want to find easier, more patient-friendly ways to screen for bowel cancer that more people will be willing to do. This is especially important as we notice more cases of bowel cancer in younger people, often linked to lifestyle factors like diet, smoking, and family history.

This study, called ONCOSCREEN, is focused on developing new, simple, and affordable screening tests that are easy to use, perhaps even at home. They want these new tests to be very good at detecting bowel cancer, even at its earliest stages. The study will be testing four different new diagnostic tools in people who have bowel cancer and in healthy individuals who are at a higher risk of developing it, to see how well these new methods work.

Key takeaways

New ways to detect bowel cancer early are being researched.
The study wants to create easy, affordable, and accurate screening tests.
It aims to improve early detection for both the general public and high-risk individuals.
Researchers are testing several new diagnostic tools.
Participation involves procedures like colonoscopy and stool tests.

Who may be eligible?

To join this study, you need to be 18 years old or older. There are two main groups of people they are looking for: those who have already been diagnosed with bowel cancer and those who are healthy but have a higher chance of getting bowel cancer.

If you have bowel cancer, you need to have a confirmed diagnosis from a colonoscopy and be willing to have a stool test, a colonoscopy, and a tissue biopsy as part of the study. You also need to have health insurance.

If you are in the healthy control group, you also need to be willing to have a stool test, a colonoscopy, and a tissue biopsy. You must have certain risk factors for bowel cancer, such as a family history of the disease, being overweight, smoking, drinking too much alcohol, or having high cholesterol. You must also have health insurance that covers a colonoscopy if you have these risk factors or symptoms like stomach pain, changes in your bowel habits, or blood in your stool.

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 health insurance?
Are you willing to have a colonoscopy and a stool test?
Do you either have a confirmed bowel cancer diagnosis OR risk factors like family history, obesity, smoking, or heavy alcohol use?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to sign a consent form, which means you understand and agree to the study procedures. You will also need to have a stool test (FOBT), undergo a colonoscopy (an examination of your bowel with a small camera), and have a tissue biopsy taken (a small sample of tissue). The exact number of visits and follow-up will depend on the phase of the study you are in, but these procedures are central to the initial assessment. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study could help researchers develop better, easier, and more affordable ways to screen for bowel cancer in the future, which could benefit many people. However, there are some potential risks associated with the procedures, such as those linked to colonoscopy (like discomfort or, rarely, complications). All procedures carry a small risk. You will be fully informed of all potential risks before you decide to join. Remember, you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (8)

Military Medical Academy Sofia, Gastroenterology Clinic, 3 Sveti Georgi Sofiiski str., Sofia 1606, Bulgaria
Verified postcode
Sofia, Bulgaria· Recruiting
University Specialised Hospital for Active Treatment of Oncology Departement of Gastroenterology.
Verified postcode
Sofia, Bulgaria· Not yet recruiting
UFC: Université de Franche-Comté Oncology department CHU Besançon
Verified postcode
Besançon, France· Not yet recruiting
MKI UKSH Lübeck
Verified postcode
Lübeck, Germany· Recruiting
UMC Mainz: University Medical Center Mainz
Verified postcode
Mainz-GE, Germany· Recruiting
LSMU: Lithuanian University of Health Sciences Gastroenterology Department,
Verified postcode
Kaunas, Lithuania· Recruiting
IPO: Instituto Português de Oncologia
Verified postcode
Porto, Portugal· Recruiting
IBO: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu București
Verified postcode
Bucharest, Romania· Not yet recruiting

Common questions

What is bowel cancer screening?

Bowel cancer screening involves tests to find cancer early, sometimes before symptoms appear, when it is easier to treat.

What is a colonoscopy?

A colonoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your large bowel (colon) and rectum.

What is a tissue biopsy?

A tissue biopsy is when a very small sample of tissue is taken from your body to be examined under a microscope, usually during a colonoscopy.

Why are they looking for new tests?

The study aims to find simpler, more patient-friendly, and highly accurate ways to screen for bowel cancer so that more people can get tested and detect cancer earlier.

What does 'high risk' mean for bowel cancer?

Being 'high risk' can mean you have a family history of bowel cancer, are overweight, smoke, drink a lot of alcohol, or have high cholesterol.

How to find out more

Federica ZILLI, PhD

federica.zilli@firalis.com +33 (0) 389911320 Official trial record

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