N/A
N=6,400
Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing
Early Cancer Detection
Bottom Line
View on ClinicalTrials.gov: NCT04213326 ↗Enrolled (actual)
6,400
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Study Data and Samples Were Used for CancerSEEK Assay Development — 712; 3870; 5; 14 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Exact Sciences Corporation
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Data and Samples Were Used for CancerSEEK Assay Development |
712; 3870; 5; 14; 10; 9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 50 or greater
- Ability to understand the nature of this study and give written informed consent
CANCER COHORT:
Either of the following:
- Histologic diagnosis of cancer with no prior systemic or definitive therapy (any stage, including, inclusive of is-situ carcinoma)
Or
- Subject with high suspicion of cancer through radiological and/or clinical assessment who are scheduled for resection or biopsy within 6 weeks of study blood collection and have not received prior systemic or definitive therapy.
NON-CANCER COHORT
- No prior history of cancer
Exclusion Criteria
ALL PATIENTS
- Evidence of active febrile infection prior to blood draw.
- Women who are pregnant or breast-feeding.
- History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
- Judgment by the Investigator or study staff of any other reason that would prohibit the inclusion of the subject in the study.
CANCER COHORT
- Subjects newly diagnosed with a hematologic malignancy, primary central nervous system tumor, prostate cancer, or skin cancer (including melanoma).
- History of, or currently receiving, systemic or definitive cancer treatment including curative surgical resection, chemotherapy, radiation therapy, immunotherapy, and hormone therapy.
NON-CANCER COHORT
- None
Data sourced from ClinicalTrials.gov (NCT04213326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.