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NCT04213326 · ClinicalTrials.gov registry record
Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing
A clinical trial of Early Cancer Detection, sponsored by Exact Sciences Corporation.
- Completed
- Registry status
- 6,400
- Enrollment target
- 14
- Study locations
NCT04213326: Completed study of Early Cancer Detection, sponsored by Exact Sciences Corporation.
NCT04213326 is a study of Early Cancer Detection that has completed, run by Exact Sciences Corporation. The registered enrollment target is 6,400 participants. The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04213326, a study of Early Cancer Detection, has completed, sponsored by Exact Sciences Corporation.
- COMPLETED
- Registry status
- 6,400 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer. Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician. Informed consent will be carried out for eligible subjects in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Subjects will then complete a survey, and study staff will draw 60 mL of blood and measure the height and weight of the subject. Where available, data from the medical records of the cancer subjects will reviewed and collected. In addition, non-cancer subjects will be requested to allow access to their medical records as an optional portion of their informed consent.
Primary Outcome
The primary objective of the study is to collect blood samples from known cancer and non cancer participants. These blood samples were used to calibrate the CancerSEEK assay. There was no pre-defined performance threshold.
Conditions Studied
Study Locations (14)
Florida
- Sarah Cannon - Fort Walton Beach
- Sarah Cannon - Ocala
- Sarah Cannon - Pensacola
Georgia
- Sarah Cannon - Augusta
- Sarah Cannon - Macon
- Sarah Cannon - Savannah
Kansas
- Sarah Cannon - Kansas City
- Sarah Cannon - Overland Park
California
- Sarah Cannon - Thousand Oaks
Colorado
- Sarah Cannon - Denver
Missouri
- Sarah Cannon - Independence
Nevada
- Sarah Cannon - Las Vegas
Tennessee
- Sarah Cannon - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,400 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2021-01-29 |
What the finished NCT04213326 record still lists
NCT04213326 is an observational study that tracks outcomes without assigning an intervention. Its 6,400 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Early Cancer Detection appearing as the primary indexed condition, and to 0 interventions.
NCT04213326 lists 14 locations in 9 states (Florida, Georgia, Kansas).
Frequently Asked Questions
What is clinical trial NCT04213326 about?
NCT04213326 is a clinical study titled "Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing". This is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer. Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician. Informed consent will be carried ...
What is the current status of trial NCT04213326?
This trial is currently completed. The enrollment target is 6,400 participants. The study started on 2019-11-18. Estimated completion is 2021-01-29.
What conditions does trial NCT04213326 study?
This clinical trial studies the following conditions: Early Cancer Detection.
Who is sponsoring clinical trial NCT04213326?
This trial is sponsored by Exact Sciences Corporation, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04213326 being conducted?
This trial has 14 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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