CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,400 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04213326
NCT04213326N/ACompleted

Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing - Ascertaining Serial Cancer Patients to Enable New Diagnostic

Exact Sciences Corporation·observational·Posted Dec 30, 2019·Updated Jun 14, 2024

In Brief

An observational study for Early Cancer Detection. Completed, enrolled 6,400 participants across 14 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 30, 2019
Enrollment StartNov 18, 2019
Primary CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.5 years ago