Performance of multiple multi-cancer detection tests using a large independent reference set (Alliance A212102).
Marie E Wood, Paul F Pinsky, Paul J Novotny...
https://pubmed.ncbi.nlm.nih.gov/41499420/Actively Recruiting
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-08-05
2000
Participants Needed
744
Research Sites
4 weeks
Total Duration
Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.
CONDITIONS
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
M
Marie Wood, MD
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Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit for questionnaire and initial blood sample collection
Duration - 12 months
Participants complete a questionnaire and provide blood samples at registration and again 12 months later. Those with cancer may also provide tissue samples at these times.
2 visits (at registration and 12 months)
Duration - 1 year
Participants are followed up for one year after completing sample collection to monitor outcomes.
Periodic follow-up contacts
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Marie E Wood, Paul F Pinsky, Paul J Novotny...
https://pubmed.ncbi.nlm.nih.gov/41499420/Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor