Prospective Study of oncRNA Stratification of Cancer by Size and Stage

Part of paid clinical trials in Palo Alto, California.

Sponsor
Exai Bio Inc.
Study ID
NCT05833360
Status
Recruiting
Apply to this trial

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exai oncRNA blood test — DEVICE
    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 Details

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.

Key Dates

Start date
Jul 14, 2023
Status verified
Mar 2025
Primary completion
Jul 14, 2030
Completion
Jul 14, 2030

Study Design

Enrollment
2,400 participants (estimated)

Arms

  • Arm: Control Cohort
    Participants without cancer, with general medical comorbidities
  • Arm: Cancer Predisposition Cohort
    Participants without cancer, with comorbidities that induce cancer predisposition.
  • Arm: Pre-Malignant Condition Cohort
    Participants without cancer, with pre-malignant conditions
  • Arm: Cancer Patients Cohort
    Participants with a cancer diagnosis.

Primary Outcome Measure

Optimize non-invasive cancer biomarker tests based on its small noncoding (snc)RNA technology [ Time Frame: Seven years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Exai Bio Inc.Palo AltoCalifornia94303
Clinical Operations Team
[email protected]
650-204-0423
Renown HealthRenoNevada89502
Renown Office of Clinical Research
[email protected]
775-982-3646
Lee S Schwartzberg, MD (PRINCIPAL_INVESTIGATOR)

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