All studies
Active not recruitingNAINTERVENTIONAL

PATHFINDER 2: A Multi-Cancer Early Detection Study

The PATHFINDER 2 study is exploring a new blood test called the GRAIL multi-cancer early detection (MCED) test. This test is designed to spot signs of many different cancers at an early stage. Researchers want to see how well it works and if it's safe for people aged 50 and older who are already getting regular cancer check-ups. If the test suggests a possible cancer, participants will have more medical checks to find out what's going on. The study also wants to understand what people think about taking this new test. Around 35,000 to 38,500 people will join from various clinics in North America, and they will be followed for about three years.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
GRAIL, Inc.
Enrolment target
35,883
Start
08 Dec 2021
Estimated completion
30 Apr 2028

What is this study about?

This study, called PATHFINDER 2, is looking at a new type of blood test. It's designed to find early signs of many different cancers from a single blood sample. Think of it like a new tool that could help doctors spot cancer sooner than traditional methods. The researchers want to see if this test, called the GRAIL multi-cancer early detection (MCED) test, is both safe and effective for people who are already having regular cancer screenings, as recommended by health guidelines.

If someone in the study gets a test result that suggests there might be a 'cancer signal,' they will have further tests. These additional tests will help doctors figure out if cancer is actually present and if so, where it might be. The study also wants to see how many different tests are needed to get a clear answer. On top of that, researchers will ask participants about their experiences and thoughts on this new multi-cancer test at different times throughout the study.

Around 35,000 to 38,500 people will be joining this study at hospitals and clinics across North America. They will be followed closely for about three years after they join. The whole aim is to gather important information to understand if this new type of early detection test could one day become a helpful part of routine healthcare for many people.

Key takeaways

  • It's a study for a new blood test that aims to find multiple cancers early.
  • Participation is for people 50 and older who get regular cancer screenings.
  • If the test indicates a 'cancer signal,' more diagnostic tests will follow.
  • The study wants to know what participants think of the test.
  • You would be in the study for about three years.

Who may be eligible?

To join this study, you need to be at least 50 years old and be able to understand and sign the consent forms. You also need to be a patient at one of the clinics taking part in the study and not have taken part in a similar GRAIL study before.

There are also reasons why you might not be able to join. For example, if you are currently being checked for a possible cancer because your doctor is suspicious, or if you've been diagnosed with most types of cancer in the last three years. If you're pregnant, you also can't take part. The study needs people who can commit to following all the study steps.

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.

  1. Are you at least 50 years old?
  2. Are you comfortable signing consent forms?
  3. Are you currently having regular cancer screening (e.g., mammogram, bowel cancer screening)?
  4. Are you NOT currently being checked for a potential cancer?
  5. Have you NOT had a cancer diagnosis (apart from some skin cancers) in the last three years, or never treated if more than three years ago?
  6. Are you NOT pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several steps over about three years. You would provide blood samples for the multi-cancer early detection test. If your test shows a 'cancer signal detected,' you would then have further diagnostic procedures, like scans or biopsies, to find out if you have cancer. The study team would help arrange these. You would also be asked to share your thoughts and feelings about the test at different points during the study through questionnaires or interviews. The overall duration you'd be actively involved and followed by the study team is around three years from when you first join.

Potential risks and benefits

Participating in this study might offer the potential benefit of finding certain cancers earlier than they might otherwise be detected. However, it's important to remember this is a research study, and the test is still being evaluated. There's a chance the test could give a 'false alarm' (suggesting cancer when there isn't any) or miss a cancer that is present. This could lead to stress or unnecessary further tests. As with any medical procedure, there are minor risks associated with blood draws, like bruising or discomfort. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (56)

  • Sutter Health
    Verified postcode
    Auburn, United States
  • Sutter Health
    Verified postcode
    Davis, United States
  • Sutter Health
    Verified postcode
    Elk Grove, United States
  • Sutter Health
    Verified postcode
    Fairfield, United States
  • HOAG Irvine
    Verified postcode
    Irvine, United States
  • HOAG Vivante Newport Mesa
    Verified postcode
    Irvine, United States
  • Long Beach Memorial Medical Center
    Verified postcode
    Long Beach, United States
  • Sutter Health
    Verified postcode
    Modesto, United States
  • HOAG Newport Beach
    Verified postcode
    Newport Beach, United States
  • Palo Alto Medical Foundation
    Verified postcode
    Palo Alto, United States
  • Sutter Health
    Verified postcode
    Sacramento, United States
  • PAMF - Santa Cruz
    Verified postcode
    Santa Cruz, United States

Common questions

What is the main goal of this study?

The main goal is to see if a new blood test can safely and effectively find different cancers early in people aged 50 and over.

Who can join this study?

Generally, people aged 50 and older who are not currently being investigated for cancer and haven't had certain cancers recently can join.

What happens if the test shows a sign of cancer?

If the test suggests a 'cancer signal,' you would have more medical tests to confirm if cancer is present and find its location.

How long will I be in the study?

You'll be followed by the study team for about three years once you've joined.

Do I have to pay to join the study?

No, you do not have to pay to take part in a clinical trial. All study-related procedures are typically provided at no cost.

How to find out more

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

Discussion

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