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Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing

NCT04213326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6400

Last updated 2024-06-14

Study results available
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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.

Conditions

  • Early Cancer Detection

Sponsors & Collaborators

  • Exact Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Dax Kurbegov, MD · Sarah Cannon

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2021-01-29
Completion
2021-01-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213326 on ClinicalTrials.gov