What side effects are associated with this type of intervention?

Blood-based cancer detection methods, such as the GRAIL Multi-Cancer Early Detection (MCED) Test, are generally non-invasive and have minimal direct side effects compared to traditional diagnostic procedures. However, potential indirect side effects include anxiety or stress related to false-positive results, which may lead to unnecessary follow-up procedures and associated risks. Additionally, there may be minor side effects from blood draws, such as bruising or infection at the puncture site.

What prior FDA approvals exist?

The GRAIL Multi-Cancer Early Detection (MCED) test is a blood-based diagnostic tool currently under study for its ability to detect multiple types of cancer early. While the context does not provide specific prior FDA approvals for similar blood-based early detection tests, it does highlight the ongoing research and interest in such technologies. The GRAIL MCED test aims to identify cancer signals in the blood, which could lead to earlier diagnosis and treatment. This approach is part of a broader trend in oncology to develop non-invasive, blood-based diagnostics to improve early cancer detection and patient outcomes.

What other types of research exist?

Promising alternatives to the GRAIL MCED test for early cancer detection in 2024 include: 1) Liquid biopsies using circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) for detecting genetic mutations and alterations associated with cancer. 2) Advanced imaging techniques such as PET/CT scans with novel tracers that improve the detection of early-stage cancers. 3) Multi-analyte assays that combine protein biomarkers, genetic markers, and other molecular signatures to enhance early detection accuracy. 4) AI-driven diagnostic tools that analyze large datasets from imaging and molecular tests to identify early cancer signals.

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Cancer Screening Test

Early Detection Test for Cancer

N/A

Waitlist Available

Research Sponsored by GRAIL, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).

Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF)

Must not have

Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new blood test called the GRAIL MCED test, which aims to detect multiple types of cancer early. GRAIL, a company formed by DNA-sequencing giant Illumina, is developing the GRAIL MCED test to detect multiple cancer types early. It targets people who are already recommended for cancer screening. The test works by looking for cancer-related DNA in the blood, and if found, further tests are done to confirm and locate the cancer.

Who is the study for?

This trial is for individuals at least 50 years old who can consent to participate and are eligible for cancer screening. They shouldn't have had invasive cancer treatment in the last 3 years, except hormone therapy for breast or prostate cancer. Participants must be registered patients at a participating center and not pregnant.

What is being tested?

The GRAIL multi-cancer early detection (MCED) test is being studied to see how safe and effective it is in detecting various cancers early on. If the test detects a potential cancer signal, participants will undergo further diagnostic procedures to confirm if they have cancer.

What are the potential side effects?

Since this study involves diagnostic testing rather than medication or intervention, traditional side effects are not applicable. However, there may be psychological impacts from receiving results indicating a potential cancer diagnosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was diagnosed with cancer within the last 3 years or have an untreated cancer diagnosed over 3 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants 50 years of age or olderExperimental Treatment1 Intervention

The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. The target age categories of 60-69 years and 70-79 years will be enriched to increase the number of cancer events that are observed during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multi-Cancer Early Detection Test

2019

N/A

~6670

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for early cancer detection, such as the GRAIL Multi-Cancer Early Detection (MCED) Test, work by analyzing blood samples to identify specific biomarkers or genetic mutations associated with cancer. These tests detect circulating tumor DNA (ctDNA) and other molecular markers, enabling the identification of multiple cancer types at an early stage. Early detection is critical as it allows for timely interventions, potentially reducing disease progression and improving survival rates for patients.