- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05833360
Prospective Study of oncRNA Stratification of Cancer by Size and Stage
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 Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Irene Acerbi, PhD
- Phone Number: 6502624516
- Email: irenea@exai.bio
Study Locations
-
-
California
-
Palo Alto, California, United States, 94303
- Recruiting
- Exai Bio Inc.
-
Contact:
- Irene Acerbi, PhD
- Phone Number: 650-262-4516
- Email: irenea@exai.bio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Cohort
Participants without cancer, with general medical comorbidities
|
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.
|
Cancer Predisposition Cohort
Participants without cancer, with comorbidities that induce cancer predisposition.
|
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.
|
Pre-Malignant Condition Cohort
Participants without cancer, with pre-malignant conditions
|
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.
|
Cancer Patients Cohort
Participants with a cancer diagnosis.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Seven years
|
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.
|
Seven years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Babak Alipanahi, PhD, Exai Bio Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Uterine Diseases
- Disease Attributes
- Gastrointestinal Diseases
- Renal Insufficiency
- Prostatic Diseases
- Gastroenteritis
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Coronary Disease
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Pancreatic Diseases
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Genital Diseases, Female
- Liver Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Kidney Diseases
- Renal Insufficiency, Chronic
- Inflammatory Bowel Diseases
- Fatty Liver
- Prostatic Hyperplasia
- Non-alcoholic Fatty Liver Disease
- Hypercholesterolemia
- Hypertrophy
- Pancreatitis
- Pancreatitis, Chronic
- Uterine Neoplasms
- Prostatitis
- Neoplasms, Cystic, Mucinous, and Serous
Other Study ID Numbers
- CP-23001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Exai oncRNA blood test
-
French National Agency for Research on AIDS and...Completed
-
Pascual Gregori RoigHospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHERCompletedHyperbilirubinemia, Neonatal | Anemia Neonatal | Polycythemia SecondarySpain
-
Wingate InstituteTel Aviv UniversityCompleted
-
University Hospital, ToursCompleted
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Minovia Therapeutics Ltd.RecruitingMyelodysplastic SyndromesIsrael
-
Centre Hospitalier Universitaire de NīmesRecruitingNeoplasm Metastasis | Colorectal Cancer | Disseminated CancerFrance
-
University Hospital, GenevaHospices Civils de LyonNot yet recruitingAbuse, Child | Protein Disorder, BloodFrance, Switzerland