Recruiting

OncRNA Stratification

Sponsor:

Exai Bio Inc.

Code:

NCT05833360

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exai oncRNA blood test

Study Details

Brief summary:

Cancer strikes about one in three women and one in two men in the U.S. and more than 600,000 die from it each year. The best chance to reduce these numbers and save lives is through early detection and intervention.

The investigators are developing a blood test to detect cancer from a simple blood draw also referred to as a liquid biopsy. This test is based on orphan non-coding RNAs (oncRNAs) that are abundant in the blood of patients with cancer and largely absent in people without cancer. Using artificial intelligence (AI) and machine learning (ML) investigators are able to interpret the thousands of oncRNAs found in the blood of patients with cancer by identifying unique, cancer-specific patterns. oncRNA patterns can be used to detect several types of cancer and detect cancer at the earliest stages.

This is a prospective, observational study to collect blood samples and medical information from participants with and without cancer to represent the population in the USA. The investigators have designed the study to include participants without cancer, participants with conditions that are a predisposition for cancer, participants with pre-malignant lesions, and participants with cancer. Patients with a wide variety of cancers are going to be included i.e. bladder, breast, colorectal, esophageal, gastric, kidney, liver, lung, ovarian, pancreatic, prostate, and uterine cancer.

Each participant will be asked to donate a small blood sample and to share their medical information. The participant's medical information will be updated during the course of the study. The blood will be tested for oncRNA. The objective is to create a blood repository and associated medical database to develop a blood test for cancer, for different cancer types. The study is designed to be inclusive and represent the population in America.

If this study is successful, the results will enable a world where cancer can be detected early with a simple blood test and diagnosed accurately, with better chances of cure. The investigators believe this study has the potential to transform cancer detection in America.

Conditions

Cancer

Study ID

NCT05833360

Start date

Jul 14, 2023

Status verified date

Mar, 2025

Completion date

Jul 14, 2030

Anticipated

Primary completion date

Jul 14, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2400 participants

Anticipated

Interventions and Outcome Measures

Arms

Control Cohort

Participants without cancer, with general medical comorbidities

Cancer Predisposition Cohort

Participants without cancer, with comorbidities that induce cancer predisposition.

Pre-Malignant Condition Cohort

Participants without cancer, with pre-malignant conditions

Cancer Patients Cohort

Participants with a cancer diagnosis.

Interventions

Exai oncRNA blood test

A phlebotomist will collect approximately 40 ml (about 2-3 tablespoons) of blood from the subjects after consent. The Exai oncRNA blood test will be run on the blood samples.

Primary outcome measure

  • Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology [ Time Frame: Seven years ]
  • Optimize oncRNA test clinical performance [ Time Frame: Seven years ]

Central Contacts and Locations

Central contacts

Clinical Operations Team

650-204-0423clinical-ops@exai.bio

Locations

Exai Bio Inc.

Recruiting

Palo Alto, California, United States, 94303

Contacts

Clinical Operations Team

650-204-0423clinical-ops@exai.bio

Renown Health

Recruiting

Reno, Nevada, United States, 89502

Contacts

Renown Office of Clinical Research

775-982-3646renown-crd@renown.org

Principal Investigator:

Lee S Schwartzberg, MD

More Information

Sponsor

Exai Bio Inc.

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Keywords

  • cancer
  • liquid biopsy
  • early detection
  • diagnostics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exai Bio Inc. on 2025-03-18.