Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing

NCT04213326 | Completed Results

• 1 other identifier: HEOR 24
• Study Type: observational
• Target: 6,400
• Locations: 1 country
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (1)

• Study Data and Samples Were Used for CancerSEEK Assay Development

  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.

  6 months

Study Arms (2)

Cancer Cohort

Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.

Non-Cancer Cohort

Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3000 total subjects 2000 healthy volunteers 1000 cancer volunteers

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Exact Sciences Corporation: lead

Study Sites (14)

Sarah Cannon

Thousand Oaks, California, 23229, United States

Location

Sarah Cannon

Denver, Colorado, 80220, United States

Location

Sarah Cannon

Fort Walton Beach, Florida, 32547, United States

Location

Sarah Cannon

Ocala, Florida, 34471, United States

Location

Sarah Cannon

Pensacola, Florida, 32514, United States

Location

Sarah Cannon

Augusta, Georgia, 30909, United States

Location

Sarah Cannon

Macon, Georgia, 31217, United States

Location

Sarah Cannon

Savannah, Georgia, 31404, United States

Location

Sarah Cannon

Kansas City, Kansas, 64012, United States

Location

Sarah Cannon

Overland Park, Kansas, 66209, United States

Location

Sarah Cannon

Independence, Missouri, 64057, United States

Location

Sarah Cannon

Las Vegas, Nevada, 89129, United States

Location

Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

Sarah Cannon

Richmond, Virginia, 23229, United States

Location

Related Publications (1)

• Post C, Braun TP, Etzioni R, Nabavizadeh N. Multicancer Early Detection Tests: An Overview of Early Results From Prospective Clinical Studies and Opportunities for Oncologists. JCO Oncol Pract. 2023 Dec;19(12):1111-1115. doi: 10.1200/OP.23.00260. Epub 2023 Oct 18.

  PMID: 37851937 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will have 6 (10 mL) biological samples (blood) collected in Streck circulating free DNA (cfDNA) tubes with a needle no larger than 21G. Tubes will be filled completely and then immediately mixed by gentle inversion 8-10 times.

Limitations and Caveats

With the acquisition of Thrive Earlier Detection by Exact Science in early 2021, the primary objective shifted. The study data and samples were used for CancerSEEK assay development only and no endpoint analysis was conducted.

Results Point of Contact

• Title: Adriann Kern
• Organization: Exact Sciences

akern@exactsciences.com

4843563027

Study Officials

• Dax Kurbegov, MD

  Sarah Cannon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: November 18, 2019
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: June 14, 2024
• Results First Posted: January 18, 2023

Record last verified: 2024-06

Locations

US (14)