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 type | Observational |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 2900 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Locations | 751 sites (Anchorage, Alaska and 750 other locations) |
| Status | Recruiting |
| Started | August 18, 2022 |
| Main results expected | January 31, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT05334069 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
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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
- Study coordinator: Marie Wood, MD
- Email: marie.wood@cuanschutz.edu
- Phone: (720) 848-0300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.