Home › Trials › NCT05334069

Collecting blood samples to evaluate tests for early cancer detection

Blinded Reference Set for Multicancer Early Detection Blood Tests

Observational Alliance for Clinical Trials in Oncology · NCT05334069

This study is collecting blood and tissue samples from people with and without cancer to see if new tests can help detect cancer earlier.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages40 Years to 75 Years
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Locations746 sites (Anchorage, Alaska and 745 other locations)
Trial IDNCT05334069 on ClinicalTrials.gov

What this trial studies

This observational study collects blood and tissue samples from patients with and without cancer to evaluate tests aimed at early cancer detection. Participants will complete a questionnaire and provide blood samples at registration and again after 12 months. Patients diagnosed with cancer may also provide tissue samples. The study aims to create a reference set of samples to validate assays for future clinical trials focused on blood-based multi-cancer early detection.

Who should consider this trial

Good fit: Ideal candidates include patients with a confirmed diagnosis of specific cancers such as leukemia or lymphoma, as well as healthy individuals for comparison.

Not a fit: Patients with cancers not included in the specified types or those who are not willing to provide blood or tissue samples may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of effective tests for the early detection of various cancers.

How similar studies have performed: Other studies have shown promise in using blood samples for early cancer detection, indicating that this approach has potential based on previous findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

      \*\*\* 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
    * 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

  \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* 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

  \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
* 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

  \* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
* 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

Where this trial is running

Anchorage, Alaska and 745 other locations

+696 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAnn Arbor Stage I LymphomaAnn Arbor Stage II LymphomaAnn Arbor Stage III LymphomaAnn Arbor Stage IV LymphomaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.