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Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Exai Bio Inc. · NCT05833360

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2400
US sites recruiting
2
Study start
July 14, 2023
Record last updated
March 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Exai oncRNA blood test

Conditions: Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Exai Bio Inc.

    Palo Alto, CA 94303

    Site contact: Clinical Operations Team · 650-204-0423 · clinical-ops@exai.bio

  • Renown Health

    Reno, NV 89502

    Site contact: Renown Office of Clinical Research · 775-982-3646 · renown-crd@renown.org

Study contacts (from the official record)

  • Clinical Operations Team · 650-204-0423 · clinical-ops@exai.bio
Prospective Study of oncRNA Stratification of Cancer by Size and Stage (NCT05833360) | Bored Studies