Prospective Study of OncRNA Stratification of Cancer by Size and Stage

Trial Title: Prospective Study of OncRNA Stratification of Cancer by Size and Stage

NCT ID: NCT05833360

Condition: Cancer

Conditions: Keywords:
cancer
liquid biopsy
early detection
diagnostics

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Exai oncRNA blood test
Description: 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.
Arm group label: Cancer Patients Cohort
Arm group label: Cancer Predisposition Cohort
Arm group label: Control Cohort
Arm group label: Pre-Malignant Condition Cohort

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.

Criteria for eligibility:

Study pop:
Eligible individuals in the USA.

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Exai Bio Inc.

Address:
City: Palo Alto
Zip: 94303
Country: United States

Status: Recruiting

Contact:
Last name: Irene Acerbi, PhD

Phone: 650-262-4516
Email: irenea@exai.bio

Facility:
Name: Renown Health

Address:
City: Reno
Zip: 89502
Country: United States

Status: Recruiting

Contact:
Last name: Renown Office of Clinical Research

Phone: 775-982-3646
Email: renown-crd@renown.org

Contact backup:
Last name: Lee S Schwartzberg, MD

Start date: July 14, 2023

Completion date: July 14, 2030

Lead sponsor:
Agency: Exai Bio Inc.
Agency class: Industry

Source: Exai Bio Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05833360
https://www.nature.com/articles/s41591-018-0230-4