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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer screening test to see if it is safe and effective. 20,000 people will be enrolled over 18 months, and will be followed for 3 years.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 50 years old or older.
Select...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result).
Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.
Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).
+5 moreSecondary outcome measures
Accuracy of initial multi-cancer early detection (MCED) test result and cancer signal origin prediction, among the subset of participants with a research blood draw.
Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.
Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.
+4 moreTrial 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
Find a Location
Who is running the clinical trial?
GRAIL, LLCLead Sponsor
7 Previous Clinical Trials
292,157 Total Patients Enrolled
1 Trials studying Early Detection of Cancer
17,000 Patients Enrolled for Early Detection of Cancer
Justin Chen, MDStudy DirectorGRAIL, LLC
1 Previous Clinical Trials
1,800 Total Patients Enrolled
Eric Fung, MD, PhDStudy DirectorGRAIL, LLC
1 Previous Clinical Trials
15,254 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer treatment in the last 3 years, except for hormone therapy.I was diagnosed with cancer within the last 3 years or have an untreated cancer diagnosed over 3 years ago.I have non-spreading skin cancer.I am able to understand and sign the consent form.I am able to understand and sign the consent form.I am 50 years old or older.I am 50 years old or older.I have not had cancer treatment, except hormone therapy, in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Participants 50 years of age or older
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Early Detection of Cancer Patient Testimony for trial: Trial Name: NCT05155605 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research endeavor still open?
"Per clinicaltrials.gov, this experiment is actively recruiting patients for participation. Initially posted on December 8th 2021, the study has since been updated to current standards as of August 4th 2022."
Answered by AI
How many participants are enrolled in the current research endeavor?
"An aggregate of 20,000 participants with the appropriate characteristics are needed to partake in this trial. Individuals can join from Texas Oncology - Fort Worth based in Fort Worth California and Sutter Health located at Auburn Maryland."
Answered by AI
At how many locations is this clinical trial being managed?
"This clinical trial is enlisting patients from 32 different medical facilities, with the most prominent being Texas Oncology - Fort Worth in Fort Worth, California, Sutter Health in Auburn and Maryland Oncology Hematologyin Annapolis."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Arkansas
California
Other
What site did they apply to?
Sutter Health
Oregon Health & Science University Knight Cancer Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent Upper endoscope detected precancerous colon polyp. I saw your study for early cancer detection and wanted to help.
PatientReceived 2+ prior treatments
I’d like to help advance medical science and earn money on the side. I’d like to advance medical science and earn some money on the side.
PatientReceived no prior treatments
My wife was recently diagnosed with ovarian cancer. Early detection would have improved her chances of cure.
PatientReceived 1 prior treatment
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