Blood test for early cancer detection using oncRNA analysis
Prospective Study of oncRNA Stratification of Cancer by Size and Stage
This study is testing a new blood test that looks for specific markers to see if it can help find cancer earlier in people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exai Bio Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT05833360 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a blood test that detects cancer through liquid biopsy by analyzing orphan non-coding RNAs (oncRNAs) found in the blood. The study will collect blood samples and medical information from participants with and without cancer to establish a comprehensive understanding of oncRNA patterns. Using artificial intelligence and machine learning, the investigators will identify unique cancer-specific patterns in the blood samples, which could enable early detection of various cancer types. The goal is to improve early intervention strategies and ultimately reduce cancer mortality rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are willing to provide informed consent and undergo a blood draw.
Not a fit: Patients with a prior history of cancer or those currently undergoing cancer treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this test could significantly enhance early cancer detection, leading to timely treatment and improved patient outcomes.
How similar studies have performed: Other studies utilizing liquid biopsy and oncRNA analysis have shown promise in early cancer detection, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Able and willing to provide informed consent * Able and willing to have 35-40 mL of whole blood drawn Exclusion Criteria: * 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
Where this trial is running
Palo Alto, California and 1 other locations
- Exai Bio Inc. — Palo Alto, California, United States (Recruiting)
- Renown Health — Reno, Nevada, United States (Recruiting)
Study contacts
- Principal investigator: Lee Schwartzberg, MD — Exai Bio Inc.
- Study coordinator: Clinical Operations Team
- Email: clinical-ops@exai.bio
- Phone: 650-204-0423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.