CancerNCT05833360
Prospective Study of oncRNA Stratification of Cancer by Size and Stage
An observational study of Cancer, run by Exai Bio Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Exai oncRNA blood test
- Type of treatment
- Medical device
- How many people
- 2,400 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2023to 14 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible individuals in the USA.
Who may be able to join
- Age ≥18 years
- Able and willing to provide informed consent
- Able and willing to have 35-40 mL of whole blood drawn
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Exai Bio Inc.
Palo Alto, California, 94303
Clinical Operations Team, 650-204-0423, clinical-ops@exai.bio
- Recruiting
Renown Health
Reno, Nevada, 89502
Renown Office of Clinical Research, 775-982-3646, renown-crd@renown.org
Lee S Schwartzberg, MD
About this study
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.
Read more
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
- Being tested
- Exai oncRNA blood test
- Keywords
- cancer, liquid biopsy, early detection, diagnostics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exai oncRNA blood testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort | Participants without cancer, with general medical comorbidities Receives: Device: Exai oncRNA blood test | |
| Cancer Predisposition Cohort | Participants without cancer, with comorbidities that induce cancer predisposition. Receives: Device: Exai oncRNA blood test | |
| Pre-Malignant Condition Cohort | Participants without cancer, with pre-malignant conditions Receives: Device: Exai oncRNA blood test | |
| Cancer Patients Cohort | Participants with a cancer diagnosis. Receives: Device: Exai oncRNA blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Seven years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start14 Jul 2023
- Primary completion14 Jul 2030 (estimated)
- Study completion14 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exai Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Schwartzberg, MD, Principal investigator, Exai Bio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833360
- Sponsor's protocol ID
- CP-23001
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30397354
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of oncRNA Stratification of Cancer by Size and Stage
- ClinicalTrials.gov ID
- NCT05833360
- Acronym / sponsor ID
- CP-23001
- Conditions
- Cancer
- Keywords
- cancer, liquid biopsy, early detection, diagnostics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Exai Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 14 Jul 2030 (estimated)
- Study completion
- 14 Jul 2030 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Cohort | – | Device: Exai oncRNA blood testParticipants without cancer, with general medical comorbidities |
| Cancer Predisposition Cohort | – | Device: Exai oncRNA blood testParticipants without cancer, with comorbidities that induce cancer predisposition. |
| Pre-Malignant Condition Cohort | – | Device: Exai oncRNA blood testParticipants without cancer, with pre-malignant conditions |
| Cancer Patients Cohort | – | Device: Exai oncRNA blood testParticipants with a cancer diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible individuals in the USA.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Able and willing to provide informed consent
- Able and willing to have 35-40 mL of whole blood drawn
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exai oncRNA blood testA 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. | Device | Cancer Patients Cohort, Cancer Predisposition Cohort, Control Cohort, Pre-Malignant Condition Cohort |
Primary outcome
Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology
Time frame: Seven years
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
Optimize oncRNA test clinical performance
Time frame: Seven years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 30397354Fish 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.
- circulating oncRNAs present a novel avenue for cancer fingerprinting using liquid biopsiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee Schwartzberg, MD principal investigator
Exai Bio Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Exai Bio Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations Team (650-204-0423, clinical-ops@exai.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology (time frame: Seven years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.