Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05833360

Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Led by Exai Bio Inc. · Updated on 2025-03-18

2400

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able and willing to provide informed consent
  • Able and willing to have 35-40 mL of whole blood drawn
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Prior history of cancer, except for non-melanoma skin cancer
  • Prior receipt of any blood products within 30 days before enrollment
  • Receipt of any cancer therapy including surgery, radiation, or medical treatment before enrollment
  • Prior receipt of any non-cancer system immune modulation therapy within the last 60 days
  • Prior history of organ transplantation
  • Current or past pregnancy within the last 12 months
  • Unable or unwilling to provide informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Exai Bio Inc.

Palo Alto, California, United States, 94303

Actively Recruiting

2

Renown Health

Reno, Nevada, United States, 89502

Actively Recruiting

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Research Team

C

Clinical Operations Team

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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