Active not recruitingOBSERVATIONAL

First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer

The CORRECT - MRD I study is investigating a new and sensitive blood test designed to detect very tiny amounts of bowel cancer cells that might remain after surgery. This is called "Minimal Residual Disease" (MRD). If you've recently had surgery for stage 2 or 3 bowel cancer and completely removed the tumour, this study might be for you. Researchers will follow participants for up to five years, taking regular blood samples to see if any cancer cells are still present. The aim is to understand if this test can help doctors predict if the cancer might come back and potentially lead to better watch-and-wait strategies for patients in the future. It's an important step in improving how we monitor and treat bowel cancer after surgery.

At a glance

Status

Active not recruiting

Sponsor

Exact Sciences Corporation

Enrolment target

416

Start

20 Jun 2023

Estimated completion

01 Dec 2027

Colorectal Cancer

What is this study about?

This study, called CORRECT - MRD I, is focused on improving how we check for bowel cancer after surgery. When someone has bowel cancer removed, doctors always try to take out all the cancer cells. However, sometimes a tiny number of cancer cells can be left behind, even if they can't be seen with standard tests. This is known as "Minimal Residual Disease" (MRD).

Doctors believe that if they can find these very small numbers of cells earlier, it might help them understand better who might be at a higher risk of their cancer coming back. The study uses a special, very sensitive blood test to look for these hidden cancer cells. This research is important because if this blood test works well, it could one day help doctors make more informed decisions about a patient's care after surgery, potentially leading to personalised treatments and better outcomes.

The study will follow participants for up to five years. During this time, researchers will collect blood samples at different points to see if the MRD test can accurately predict if cancer might return. The goal is to gather vital information that could change how bowel cancer is monitored and treated in the future.

Key takeaways

This study investigates a new blood test for tiny bowel cancer cells after surgery.
It's for people who've had stage 2 or 3 bowel cancer completely removed.
Participants will have regular blood tests for up to five years.
No new treatments are given; it's focused on 'Minimal Residual Disease' (MRD) detection.
The goal is to improve future monitoring and treatment of bowel cancer.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had surgery to remove their bowel cancer. Specifically, you need to have had all of your stage 2 or stage 3 bowel cancer completely removed by surgery within the last six months.

It's important that your surgeon believes they took out all of the visible tumour, and that tests on the removed tissue confirmed no cancer cells were left at the edges. You also need to be generally well and able to give your informed consent to take part.

You would not be able to join if you have already started chemotherapy or other treatments after your surgery for this bowel cancer. Also, if you've had other cancers recently (within the last three years, except for some skin cancers), or if you've had certain organ transplants, you might not be eligible. If you're pregnant or breastfeeding, you also can't take part.

Quick self-check

Are you 18 years old or older?
Have you recently had surgery that completely removed your stage 2 or 3 bowel cancer?
Has it been less than six months since your last bowel cancer surgery?
Have you NOT started any additional 'adjuvant' treatment (like chemotherapy) for this cancer yet?
Are you generally well and able to give regular blood samples?

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

What does participation involve?

If you decide to take part in this study, you will be followed for up to five years after your surgery. The main thing you'll be doing is providing blood samples regularly. For each blood test, about 35ml of blood will be taken, which is roughly two-and-a-half tablespoons.

These blood tests will be used to check for those tiny cancer cells (MRD) that the study is investigating. You'll also continue with your usual follow-up care as recommended by your doctors. There are no new medications or treatments given as part of this specific study; it's focused on monitoring and detection. You'll have regular appointments for these blood tests during the five-year period.

Potential risks and benefits

A potential benefit of joining this study is contributing to important research that could improve how bowel cancer is monitored and treated for future patients. While there are no direct health benefits to you personally from taking part, the information gained might help doctors better understand your own situation. The main risk involved in participation is the discomfort and small risk of bruising or infection from regular blood tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Tel Aviv Sourasky Medical Center
Tel Aviv Yaffo, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Soroka University Medical Center
Beersheba, Israel
HaEmek Medical Center
Afula, Israel
Hadassah University Hospital - Mount Scopus
Jerusalem, Israel
Shaare Zedek Medical Center Jerusalem
Jerusalem, Israel
Istituto Clinico Humanitas
Rozzano, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Istituto Nazionale Tumori - Fondazione G Pascale
Naples, Italy
National Cancer Center Hospital East
Kashiwa, Japan
Hokkaido Cancer Center
Sapporo, Japan
Kagawa University Hospital
Kita-gun, Japan

+10 more sites — see the official record for the full list.

Common questions

What is 'Minimal Residual Disease' (MRD)?

MRD refers to tiny amounts of cancer cells that might be left in your body after surgery, even if standard tests can't find them.

Will I get any special treatment in this study?

No, this study is about monitoring and detecting cancer cells through blood tests, not about giving new treatments. You will continue to receive your standard medical care.

How often will I need blood tests?

You will have regular blood tests over a period of up to five years, as part of the study's monitoring schedule.

Will knowing my MRD status change my treatment?

In this study, your MRD results are mainly for research. Any treatment decisions will still be made by your doctors based on your overall medical situation and standard guidelines.

What if I change my mind about participating?

You can leave the study at any time, for any reason, without having to explain why. It won't affect the care you receive from your doctors.