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Prospective Study of oncRNA Stratification of Cancer by Size and Stage

NCT05833360 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2025-03-18

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Exai Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Lee Schwartzberg, MD · Exai Bio Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2030-07-14
Completion
2030-07-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05833360 on ClinicalTrials.gov