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Observational Study of Exai oncRNA Blood Test for Cancer Detection

This study is looking at a new blood test called the Exai oncRNA blood test to find cancer early. Researchers believe that special small noncoding RNAs (oncRNAs) are found in the blood of people with cancer but not in healthy people. By using artificial intelligence (AI) and machine learning (ML), they hope to find unique cancer patterns in these oncRNAs. The goal is to make this blood test better at finding cancer and to improve how well it works. You can join if you are 18 or older, are willing to give informed consent, and can have about 2-3 tablespoons of blood drawn. This study is currently observational, meaning it's focused on gathering information rather than testing a treatment.

Study design
This is an observational study aiming to enroll 2400 participants. It is not specified if it is randomized or blinded.
What's involved
You would need to provide informed consent and have approximately 40 ml (about 2-3 tablespoons) of blood drawn by a phlebotomist.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study will be measured at seven years.

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NCT05833360

Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Recruiting
Not specifiedAges 18+Observational
Exai Bio Inc.
~2,400 participants
Updated 2025-03-18 on ClinicalTrials.gov
What's tested:Exai oncRNA blood test

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology
Measured over Seven years
+1 more outcome measured

Conditions

Cancer

Explore related trials

Malignant Neoplasm

Where it's being run

2 sites across 2 states
California1
Nevada1

Study leadership

  • Lee Schwartzberg, MD · PRINCIPAL_INVESTIGATOR · Exai Bio Inc.

Who to contact

Clinical Operations Team
[email protected]
650-204-0423
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 years
Able and willing to provide informed consent
Able and willing to have 35-40 mL of whole blood drawn

Exclusion

Age \<18 years
Prior history of cancer, except for non-melanoma skin cancer
Prior history of receipt of any blood products within 30 days of enrollment
Receipt of any cancer therapy, e.g., surgical, radiation, or medical including neoadjuvant treatment, prior to study enrollment
Prior history of receipt of any non-cancer system immune modulation therapy within the last 60 days (ex: monoclonal antibodies)
Prior history of organ transplantation
Current or prior pregnancy within the last 12 months
Unable or unwilling to provide informed consent

What this trial measures

  • Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technologySeven years

    Analyze small noncoding (snc)RNA profiles differentially expressed in specimens obtained from case and control subjects to identify candidate sncRNA biomarkers for use in deriving and optimizing oncRNA diagnostic models for multiple cancer applications, including screening, early diagnosis, minimal residual disease and monitoring for tumor recurrence

  • Optimize oncRNA test clinical performanceSeven years

    Assess small noncoding (snc)RNA profiles potentially associated with demographic parameters, medication use, comorbid conditions, and/or cancer-predisposing conditions which might overlap with candidate cancer biomarkers to optimize oncRNA model clinical specificity performance, i.e., minimize false positives.