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Multi-Cancer Early Detection Test for Early Detection of Cancer

Duke University Health System, Durham, NC
Early Detection of Cancer+1 More ConditionsMulti-Cancer Early Detection Test - Device
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Early Detection of Cancer
  • Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

8 Primary · 7 Secondary · Reporting Duration: Up to 3 Years

Up to 3 Years
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.
Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
Participants-reported perceptions about the multi-cancer early detection (MCED) test including satisfaction with the MCED tests and attitudes towards subsequent MCED testing assessed via questionnaire at various time points during the study.
Per-participant radiation exposure during diagnostic evaluation for test positive participants.
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).
Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).
Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).
Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).
Test performance: diagnosis of invasive cancer, assessed by sensitivity.
Test performance: diagnosis of invasive cancer, assessed by specificity.

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Participants 50 years of age or older
1 of 1

Experimental Treatment

20000 Total Participants · 1 Treatment Group

Primary Treatment: Multi-Cancer Early Detection Test · No Placebo Group · N/A

Participants 50 years of age or older
Device
Experimental Group · 1 Intervention: Multi-Cancer Early Detection Test · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multi-Cancer Early Detection Test
2019
N/A
~6670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

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
Eric Fung, MD, PhDStudy DirectorGRAIL, LLC

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
Sutter Health100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "Recent Upper endoscope detected precancerous colon polyp"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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