The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Completed

• Conditions: Newly-diagnosed Cancers; Non-cancer Controls

• Registration Number: NCT05516927
• Lead Sponsor: Freenome Holdings Inc.

Brief Summary

This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-09-06
• Primary Completion: 2023-12-20
• Study Completion: 2024-05-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 788

Inclusion Criteria

• Age ≥30 years within 30 days of enrollment
• Able and willing to provide blood samples per protocol
• Able to comprehend and willing to sign and date the informed consent and HIPAA
• Authorization documents
• Able and willing to allow existing health data to be utilized for study purposes

Key

Exclusion Criteria

• Any history of solid organ or bone marrow transplantation
• Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment
• Received a blood transfusion in the 30 days preceding enrollment
• A medical condition that, in the opinion of the Investigator, should preclude enrollment in the study
• Known to be pregnant
• Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
• Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment
• Participated or currently participating in another Freenome-sponsored clinical study
• For non-cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
• For the cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants	12 months	To compare blood samples from cancer case and non-cancer control subjects in order to develop and characterize blood-based multiomics tests in specific cancer types or in a combination of multiple cancers.

Trial Locations

Locations (23)

Crisp Regional Hospital; 🇺🇸 Cordele, Georgia, United States

Silver Cross Hospital and Medical centers; 🇺🇸 Orland Park, Illinois, United States

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Margaret Mary; 🇺🇸 Batesville, Indiana, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

Allina Health Cancer Institute; 🇺🇸 Minneapolis, Minnesota, United States

Winona Health System; 🇺🇸 Winona, Minnesota, United States

Carroll County Memorial Hospital; 🇺🇸 Carrollton, Missouri, United States

Hannibal Regional Hospital; 🇺🇸 Hannibal, Missouri, United States

University Health Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

Scroll for more (13 remaining)