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Completed

NCT Number: NCT05516927

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Crisp Regional Hospital, Cordele, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

Freenome Test

Diagnostic Test

Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.

Primary outcomes

  1. Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Freenome Holdings Inc.

Industry

Registry information

Official study title

The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 26, 2022
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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