Blood Test for Cancer Detection

(PROCARES Trial)

Recruiting at 29 trial locations

Overseen By Nate Ruffle-Deignan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harbinger Health

Disqualifiers: Prior cancer, Febrile illness, Pregnancy, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new blood-based test designed to help doctors detect cancer early. It targets individuals with symptoms or signs that raise a doctor's suspicion of cancer, as well as those recently diagnosed but not yet treated. It suits those experiencing unexplained symptoms that might indicate cancer and who are undergoing or have just completed diagnostic tests. As a Phase 3 trial, this represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking cancer detection method.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this blood test is safe for cancer detection?

Research shows that taking a blood sample to check for cancer is generally safe. This involves drawing a small amount of blood, a common medical procedure that most people handle well.

Studies using similar blood tests for cancer detection have reported no major safety issues. Although these tests can sometimes give incorrect results, they do not physically harm participants. This evidence suggests that giving a blood sample poses low risk for those considering joining this type of clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new diagnostic aid for cancer, aiming to improve early detection. Unlike traditional diagnostic methods that often require invasive procedures or rely heavily on imaging, this new approach could provide a less invasive, more accessible way to identify cancer in its early stages. By potentially offering earlier and more accurate detection, this method could enable faster intervention, improving treatment outcomes and patient survival rates.

Who Is on the Research Team?

Luke Pike, MD, DPhil

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

1. undergoing diagnostic work-up to determine if cancer is present, but do not yet have a confirmed cancer diagnosis. Subject must be willing to undergo a standard diagnostic work-up per local SoC to establish clinical truth regarding the presence or absence of cancer OR 2. have a confirmed diagnosis of cancer, determined within 45 days prior to signing the Informed Consent Form, based on standard diagnostic procedures (histopathology, imaging, etc.) following presentation with symptoms, signs, and/or findings that raised a clinical suspicion of one or more cancers originating from the protocol-specified sites. Must be treatment-naïve for the diagnosed cancer at the time of enrollment.

I am 45 years old or older.

I have signed and dated the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Subjects complete a blood draw for analysis by the investigational diagnostic aid test

1 week

1 visit (in-person)

Follow-up

Participants are monitored for clinical outcomes following standard-of-care diagnostic work-up

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood sample collection

How Is the Trial Designed?

Group I: Patients with clinical suspicion of cancer or patients recently diagnosed with Cancer Experimental Treatment 1 Intervention

People who have signs, symptoms, and/or findings that their doctor suspects may be related to cancer, or who have recently been diagnosed with cancer and have not received treatment for this cancer.

Who Is Running the Clinical Trial?

Harbinger Health

Lead Sponsor

Trials

1

Recruited

10,000+

Citations

1.

galleri.com

galleri.com/

Blood Test for Cancer Screening | Galleri®

The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur.

2.

friendsofcancerresearch.org

friendsofcancerresearch.org/publication/multi-cancer-early-detection-screening-tests-considerations-for-use-of-real-world-data/

Multi-Cancer Early Detection Screening Tests

Cancers that are detected in late stages generally have a worse prognosis compared to cancers detected in earlier stages, when tumors are more amenable to ...

3.

cancer.org

cancer.org/cancer/screening/multi-cancer-early-detection-tests.html

Multi-cancer Detection (MCD) Tests

MCD tests check blood or other body fluid (such as urine or saliva) samples for signs of cancer, such as pieces of DNA, RNA, or proteins from ...

4.

grail.com

grail.com/press-releases/grail-pathfinder-2-results-show-galleri-multi-cancer-early-detection-blood-test-increased-cancer-detection-more-than-seven-fold-when-added-to-uspstf-a-and-b-recommended-screenings/

GRAIL PATHFINDER 2 Results Show Galleri® Multi ...

The Galleri test detected a cancer signal in 216 participants (cancer signal detection rate of 0.93%), and of those, cancer was diagnosed in 133 ...

5.

nature.com

nature.com/articles/s41467-025-64094-7

Real-world data and clinical experience from over ...

Cancer signal detection rate was 0.91% (1011/111,080), consistent with clinical studies and independent modeled values. Providers reported ...