Evaluating Tests for Early Cancer Detection
This study is collecting blood and tissue samples from people with and without cancer to help researchers develop better tests for finding cancer early. The study aims to create a collection of these samples that can be used to check how well new early cancer detection tests work. Researchers will look at how these tests perform for different types and stages of cancer. You may be able to join if you are between 40 and 75 years old and have a confirmed cancer diagnosis (like certain leukemias or lymphomas) or do not have cancer. The study involves completing a questionnaire and providing blood samples, and possibly tissue samples if you have cancer. The goal is to provide a set of samples to validate new blood-based tests for early cancer detection.
- Study design
- This is an observational study planning to enroll 2000 participants. It is designed to provide a blinded set of cancer versus non-cancer blood samples.
- What's involved
- You would complete a questionnaire and provide blood samples at the start and again at 12 months. If you have cancer, you might also provide tissue samples at these times.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up at 1 year after the study is completed.
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NCT05334069
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Recruiting
Not specifiedAges 40–75ObservationalAlliance for Clinical Trials in OncologyInvestigator-initiated
~2,000 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Questionnaire AdministrationBiospecimen Collection
At a glance
Recruiting sites
618 of 744 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Provision of blinded reference set of cancer versus non-cancer blood samples
Measured over Up to 1 year
Conditions
Where it's being run
744 sites across 45 statesMichigan84
Ohio61
Wisconsin61
Illinois60
Minnesota56
Nevada41
Colorado40
California30
Study leadership
- Marie Wood, MD · STUDY_CHAIR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with a cancer diagnosis: Documentation of disease:
Histologic documentation: Histologically confirmed diagnosis of invasive cancer
Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma
For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\])
For lymphoma: Stage I-IV based on Ann Arbor staging
For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
One of the following tumor types:
Colorectal
Bladder
Head and neck
Hepatobiliary
Lung
Lymphoma
Leukemia
Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
Multiple myeloma
Gastric, esophageal or gastroesophageal
Breast
Thyroid
Kidney
For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
Endometrium
Prostate
Melanoma
Sarcoma
Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention
Participants with a cancer diagnosis: Age \>= 40 and =\< 75
Participants with a cancer diagnosis: No known current pregnancy by self-report
Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
Participants with a cancer diagnosis: Willingness to provide blood samples for research use
Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
Participants with a cancer diagnosis: No history of organ transplantation
Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish
Participants without a cancer diagnosis and without suspicion of cancer: Age \>= 40 and =\< 75
Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish
Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw
Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
Participants with a high suspicion of cancer: Age \>= 40 and =\< 75
Participants with a high suspicion of cancer: No known current pregnancy by self-report
Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
Participants with a high suspicion of cancer: No history or organ transplantation
Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
What this trial measures
- Provision of blinded reference set of cancer versus non-cancer blood samplesUp to 1 year
Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.