RECRUITING

Prospective Study of OncRNA Stratification of Cancer by Size and Stage

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Study of OncRNA Stratification of Cancer by Size and Stage

Quick Facts

Study Start:2023-07-14
Study Completion:2030-07-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05833360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * Able and willing to provide informed consent
  3. * Able and willing to have 35-40 mL of whole blood drawn
  1. * Age \<18 years
  2. * Prior history of cancer, except for non-melanoma skin cancer
  3. * Prior history of receipt of any blood products within 30 days of enrollment
  4. * Receipt of any cancer therapy, e.g., surgical, radiation, or medical including neoadjuvant treatment, prior to study enrollment
  5. * Prior history of receipt of any non-cancer system immune modulation therapy within the last 60 days (ex: monoclonal antibodies)
  6. * Prior history of organ transplantation
  7. * Current or prior pregnancy within the last 12 months
  8. * Unable or unwilling to provide informed consent

Contacts and Locations

Study Contact

Irene Acerbi, PhD
CONTACT
6502624516
irenea@exai.bio

Principal Investigator

Babak Alipanahi, PhD
PRINCIPAL_INVESTIGATOR
Exai Bio Inc.

Study Locations (Sites)

Exai Bio Inc.
Palo Alto, California, 94303
United States
Renown Health
Reno, Nevada, 89502
United States

Collaborators and Investigators

Sponsor: Exai Bio Inc.

  • Babak Alipanahi, PhD, PRINCIPAL_INVESTIGATOR, Exai Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14
Study Completion Date2030-07-14

Study Record Updates

Study Start Date2023-07-14
Study Completion Date2030-07-14

Terms related to this study

Keywords Provided by Researchers

  • cancer
  • liquid biopsy
  • early detection
  • diagnostics

Additional Relevant MeSH Terms

  • Cancer