Using a Blood Test to Detect Early Cancer Recurrence After Treatment (ORACLE)

About the Study

This study is testing whether a type of blood test called a liquid biopsy can find very small amounts of cancer left in the body after treatment—before cancer shows up on scans or causes symptoms.The blood test looks for circulating tumor DNA (ctDNA), tiny pieces of cancer DNA that may be present in the bloodstream. Researchers want to learn how well this test can:

• Detect cancer recurrence early
• Predict outcomes after treatment
• Support future use of blood‑based monitoring instead of—or in addition to—imaging tests.

What the Study Involves

This study is enrolling people with different types of cancer. Check eligibility for cancer types that are eligible. 

This is an observational study, which means:

• Participants do not receive a study drug.
• Participants will receive standard of care treatment and follow-up.

If you join:

• Blood samples are collected at enrollment and during routine follow‑up visits.
• Blood draws may continue for up to 5 years.
• Researchers compare blood test results with clinical outcomes, such as whether and when cancer returns.
• Participants do not receive their blood test results. 

This study is open to people 18 years or older with any of the following:

• Have been treated for early‑stage or high‑risk cancer with curative intent (such as surgery, radiation, and/or chemotherapy)
• Are planning to receive routine follow‑up care to monitor for recurrence
• Are willing to provide blood samples during follow‑up visits

This study includes people treated for several cancers, including:

• Bladder cancer that has invaded the muscle, or ureter or kidney pelvis cancer stage 2-3 
• Breast cancer
  • Must be considered high-risk for recurrence
  • HER2-positive, triple-negative and HR-positive may all be eligible
• Endometrial cancer stage 2-3
• Esophageal or gastro-esophageal junction cancers stage 2-3
• Gastric cancer stage 2-3 
• Head and neck squamous cells cancers stage 1-4B
• Kidney cancer grade 3-4, stage 2-3 or limited (resectable) stage 4 treated with curative intent)
• Lung cancer
• Melanoma stage 2B-3 or stage 4 if treated with curative intent
• Ovarian or fallopian tube cancer
  • Stage 1C, stage 2 or stage 3
  • Stage 1A or stage 1B for high-grade serous or clear cell ovarian cancer
• Pancreatic cancer that is has been surgically removed or is eligible for surgical removal
• Rectal cancer after receiving pre-surgical treatment

People with any of the following are not eligible:

• Neuroendocrine cancer.
• History of another primary cancer diagnosed within 3 years of enrollment.
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