Prospective Study of oncRNA Stratification of Cancer by Size and Stage
1 other identifier
observational
2,400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedStudy Start
First participant enrolled
July 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 14, 2030
March 18, 2025
March 1, 2025
7 years
April 17, 2023
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology
Analyze small noncoding (snc)RNA profiles differentially expressed in specimens obtained from case and control subjects to identify candidate sncRNA biomarkers for use in deriving and optimizing oncRNA diagnostic models for multiple cancer applications, including screening, early diagnosis, minimal residual disease and monitoring for tumor recurrence
Seven years
Optimize oncRNA test clinical performance
Assess small noncoding (snc)RNA profiles potentially associated with demographic parameters, medication use, comorbid conditions, and/or cancer-predisposing conditions which might overlap with candidate cancer biomarkers to optimize oncRNA model clinical specificity performance, i.e., minimize false positives.
Seven years
Study Arms (4)
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
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.
Eligibility Criteria
Eligible individuals in the USA.
You may qualify if:
- Age ≥18 years
- Able and willing to provide informed consent
- Able and willing to have 35-40 mL of whole blood drawn
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exai Bio Inc.lead
Study Sites (2)
Exai Bio Inc.
Palo Alto, California, 94303, United States
Renown Health
Reno, Nevada, 89502, United States
Related Publications (1)
Fish L, Zhang S, Yu JX, Culbertson B, Zhou AY, Goga A, Goodarzi H. Cancer cells exploit an orphan RNA to drive metastatic progression. Nat Med. 2018 Nov;24(11):1743-1751. doi: 10.1038/s41591-018-0230-4. Epub 2018 Nov 5.
PMID: 30397354BACKGROUND
Related Links
Biospecimen
Blood samples
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Lee Schwartzberg, MD
Exai Bio Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2023
First Posted
April 27, 2023
Study Start
July 14, 2023
Primary Completion (Estimated)
July 14, 2030
Study Completion (Estimated)
July 14, 2030
Last Updated
March 18, 2025
Record last verified: 2025-03