Recruiting

Blood Test to Detect Cancer Return After Treatment

Plain-English translation of NCT05059444 on ClinicalTrials.gov ↗ · Source last updated August 2025 · Translation generated June 2026 · How we translate trials

What is this trial?

The ORACLE study is testing a new blood test called a ctDNA assay that may be able to detect signs of cancer returning before it shows up on scans or causes symptoms. Researchers want to learn if this simple blood test can reliably catch cancer recurrence early in patients who have been treated for common solid tumors like lung cancer, breast cancer, bladder cancer, and others. The goal is to see if this medication could help doctors monitor patients more effectively during follow-up care.

After treatment for early-stage cancer, doctors need reliable ways to catch recurrence as early as possible. Currently, doctors rely on imaging scans and clinical exams, which may not detect cancer returning until it's more advanced. This study exists to see if the new blood test could give doctors an earlier warning sign, potentially allowing for faster treatment and better outcomes.

Do you qualify?

You likely qualify if…

you are 18 years old or older
you have been diagnosed with early-stage cancer (such as bladder, lung, breast, melanoma, pancreatic, head and neck, ovarian, endometrial, or renal cancer) and have received treatment with curative intent
you are planning to have regular follow-up visits with your doctor as part of standard cancer care
you are willing to provide blood samples at enrollment and during follow-up visits for up to 5 years
you are willing to share de-identified clinical information with study researchers

You likely don't qualify if…

you have a history of organ or tissue transplant
your cancer has predominantly neuroendocrine histology (a specific cell type)
you have been diagnosed with another primary cancer within the past 3 years (except certain low-risk skin or prostate cancers)

What participation looks like

Participants will provide blood samples at the time they enroll in the study and then at follow-up visits that coincide with their regular cancer monitoring appointments—potentially over up to 5 years. The blood samples will be tested with the new ctDNA assay to see if it can detect any signs of cancer recurrence. Between visits, participants will continue their standard care with their oncologist, and researchers will track their clinical outcomes to link blood test results with real health outcomes.

AI-generated summary from trial data · Jun 4, 2026 · Not medical advice

Trial locations(57 sites)

United States

University of Alabama at Birmingham, Birmingham, Alabama

Ironwood Cancer & Research Centers, Chandler, Arizona

Genesis Cancer Center, Hot Springs, Arkansas

University of California, San Diego, La Jolla, California

Hoag Memorial Hospital Presbyterian, Newport Beach, California