Clinical trial Recruiting at 619 sites Observational Ages 40 to 75

Collecting blood samples to evaluate tests for early cancer detection

Official title: Blinded Reference Set for Multicancer Early Detection Blood Tests

Run by Alliance for Clinical Trials in Oncology · NCT05334069 · Data updated 2026-11-12

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
Ages40 Years to 75 Years
SexAll
Enrollment2900 (estimated)
SponsorAlliance for Clinical Trials in Oncology
Academic / other
Locations751 sites (Anchorage, Alaska and 750 other locations)
StatusRecruiting
StartedAugust 18, 2022
Main results expectedJanuary 31, 2027
Study endsFebruary 28, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT05334069 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

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 (any type): 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 (synchronous cancers are not allowed and all neuroendocrine tumors are excluded):

    * Colorectal
    * Bladder
    * Head and neck
    * Hepatobiliary

      \*\*\* 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
    * 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

      \*\*\* 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
    * Prostate
* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision)
* 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 other than the current cancer diagnosis. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.
* 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, hepatobiliary cancer, endometrial 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. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.
* 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 it's running

  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Women's Cancer Care
    Anchorage, Alaska, United States
    Recruiting
  • Katmai Oncology Group
    Anchorage, Alaska, United States
    Recruiting
  • Providence Alaska Medical Center
    Anchorage, Alaska, United States
    Recruiting
Show 44 more locations
  • Kingman Regional Medical Center
    Kingman, Arizona, United States
    Recruiting
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona, United States
    Recruiting
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas, United States
    Recruiting
  • CARTI Cancer Center
    Little Rock, Arkansas, United States
    Recruiting
  • Mission Hope Medical Oncology - Arroyo Grande
    Arroyo Grande, California, United States
    Recruiting
  • PCR Oncology
    Arroyo Grande, California, United States
    Recruiting
  • AIS Cancer Center at San Joaquin Community Hospital
    Bakersfield, California, United States
    Recruiting
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, United States
    Recruiting
  • Mercy Cancer Center - Carmichael
    Carmichael, California, United States
    Recruiting
  • Mercy San Juan Medical Center
    Carmichael, California, United States
    Recruiting
  • Mercy Cancer Center - Elk Grove
    Elk Grove, California, United States
    Recruiting
  • Veterans Affairs Loma Linda Healthcare System
    Loma Linda, California, United States
    Recruiting
  • Tibor Rubin VA Medical Center
    Long Beach, California, United States
    Recruiting
  • Contra Costa Regional Medical Center
    Martinez, California, United States
    Recruiting
  • Mercy Cancer Center
    Merced, California, United States
    Recruiting
  • Providence Queen of The Valley
    Napa, California, United States
    Recruiting
  • Eisenhower Medical Center
    Rancho Mirage, California, United States
    Recruiting
  • Mercy Cancer Center - Rocklin
    Rocklin, California, United States
    Recruiting
  • Mercy Cancer Center - Sacramento
    Sacramento, California, United States
    Recruiting
  • Pacific Central Coast Health Center-San Luis Obispo
    San Luis Obispo, California, United States
    Recruiting
  • Dominican Santa Cruz Hospital
    Santa Cruz, California, United States
    Recruiting
  • Mission Hope Medical Oncology - Santa Maria
    Santa Maria, California, United States
    Recruiting
  • Providence Medical Foundation - Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Providence Santa Rosa Memorial Hospital
    Santa Rosa, California, United States
    Recruiting
  • Saint Helena Hospital
    St. Helena, California, United States
    Recruiting
  • Saint Joseph's Medical Center
    Stockton, California, United States
    Recruiting
  • Stockton Hematology Oncology Medical Group
    Stockton, California, United States
    Recruiting
  • John Muir Medical Center-Walnut Creek
    Walnut Creek, California, United States
    Recruiting
  • Woodland Memorial Hospital
    Woodland, California, United States
    Recruiting
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado, United States
    Recruiting
  • UCHealth University of Colorado Hospital
    Aurora, Colorado, United States
    Recruiting
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado, United States
    Recruiting
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado, United States
    Recruiting
  • Saint Francis Cancer Center
    Colorado Springs, Colorado, United States
    Recruiting
  • AdventHealth Porter
    Denver, Colorado, United States
    Recruiting
  • CommonSpirit Cancer Center Mercy
    Durango, Colorado, United States
    Recruiting
  • Mercy Medical Center
    Durango, Colorado, United States
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado, United States
    Recruiting
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado, United States
    Recruiting
  • UCHealth Greeley Hospital
    Greeley, Colorado, United States
    Recruiting
  • CommonSpirit Saint Anthony Hospital Cancer Center
    Lakewood, Colorado, United States
    Recruiting
  • AdventHealth Littleton
    Littleton, Colorado, United States
    Recruiting
  • Longmont United Hospital
    Longmont, Colorado, United States
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado, United States
    Recruiting

+701 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.