Actively Recruiting
Blinded Reference Set for Multicancer Early Detection Blood Tests
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-06-02
2000
Participants Needed
746
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.
CONDITIONS
Brief Title
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 75 years
- Participants with a cancer diagnosis must have histologically confirmed invasive cancer, stages I-IV per AJCC 7th edition, or specific staging for leukemia, lymphoma, and multiple myeloma
- Participants with a cancer diagnosis must have no prior cancer treatment
- Participants with a cancer diagnosis must have no known current pregnancy
- Participants must be willing to provide blood samples for research
- Participants must have no medical contraindications to blood draw of 60 mL
- Participants must have no history of organ transplantation
- Participants must be able to read and understand English or Spanish
- Participants without cancer must have no known current pregnancy or history of invasive cancer
- Participants with high suspicion of certain cancers (ovarian, pancreatic, kidney, melanoma) with planned confirmation within 28 days may be eligible
You will not qualify if you...
- History of organ transplantation
- Known current pregnancy
- Prior history of invasive or in situ malignancy other than current cancer diagnosis (excluding non-melanoma skin cancers)
- Medical conditions preventing safe blood draw of 60 mL
- Inability to read or understand English or Spanish
Research Team
M
Marie Wood, MD
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