Blinded Reference Set for Multicancer Early Detection Blood Tests EARLY DETECTION BLOOD TESTS

What's the purpose of this trial?

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

This trial is currently open and accepting patients.


What will happen during the trial?

PRIMARY OBJECTIVE:

I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection.

SECONDARY OBJECTIVES:

I. Evaluate test performance at the time of initial cancer diagnosis by tumor type.

II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage.

OUTLINE:

Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

After completion of study, participants are followed up at 1 year.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Observational Trial

Enrollment: 2,000 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alaska

Anchorage Associates in Radiation Medicine

Anchorage, AK

Open and Accepting

Anchorage Radiation Therapy Center

Anchorage, AK

Open and Accepting

Alaska Breast Care and Surgery LLC

Anchorage, AK

Open and Accepting

Alaska Oncology and Hematology LLC

Anchorage, AK

Open and Accepting

Alaska Women's Cancer Care

Anchorage, AK

Open and Accepting

Anchorage Oncology Centre

Anchorage, AK

Open and Accepting

Katmai Oncology Group

Anchorage, AK

Open and Accepting

Providence Alaska Medical Center

Anchorage, AK

Open and Accepting

Fairbanks Memorial Hospital

Fairbanks, AK

Open and Accepting

Arizona

Kingman Regional Medical Center

Kingman, AZ

Open and Accepting

Cancer Center at St. Joseph's

Phoenix, AZ

Open and Accepting

Arkansas

Mercy Hospital Fort Smith

Fort Smith, AR

Open and Accepting

CARTI Cancer Center

Little Rock, AR

Open and Accepting

California

Dignity Health Mission Hope Cancer Center - Arroyo Grande

Arroyo Grande, CA

Open and Accepting

PCR Oncology

Arroyo Grande, CA

Open and Accepting

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, CA

Open and Accepting

Mercy Cancer Center Mercy San Juan Medical Center

Carmichael, CA

Open and Accepting

John Muir Medical Center

Concord, CA

Open and Accepting

Epic Care (Dublin)

Dublin, CA

Open and Accepting

Mercy Cancer Center - Elk Grove

Elk Grove, CA

Open and Accepting

Epic Care (Emeryville)

Emeryville, CA

Open and Accepting

Veterans Affairs Loma Linda Healthcare System

Loma Linda, CA

Open and Accepting

Tibor Rubin VA Medical Center

Long Beach, CA

Open and Accepting

Contra Costa Regional Medical Center

Martinez, CA

Open and Accepting

Providence Queen of The Valley

Napa, CA

Open and Accepting

Bay Area Tumor Institute

Oakland, CA

Open and Accepting

Eisenhower Medical Center

Rancho Mirage, CA

Open and Accepting

Mercy Cancer Center - Rocklin

Rocklin, CA

Open and Accepting

Mercy Cancer Center

Sacramento, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Saint Helena Hospital

Saint Helena, CA

Open and Accepting

SLO Oncology & Hematology Health Center Pacific Central Coast Health Center

San Luis Obispo, CA

Open and Accepting

Mission Hope Cancer Center (Santa Maria) Central Coast Medical Oncology

Santa Maria, CA

Open and Accepting

Providence Medical Foundation - Santa Rosa

Santa Rosa, CA

Open and Accepting

Sutter Santa Rosa Regional Hospital

Santa Rosa, CA

Open and Accepting

Epic Care Cyberknife Center

Walnut Creek, CA

Open and Accepting

John Muir Medical Center

Walnut Creek, CA

Open and Accepting

Woodland Memorial Hospital

Woodland, CA

Open and Accepting

Colorado

Rocky Mountain Cancer Centers

Aurora, CO

Open and Accepting

The Medical Center of Aurora (HealthONE)

Aurora, CO

Temporarily Suspended

Rocky Mountain Regional VA Medical Center

Aurora, CO

Open and Accepting

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Rocky Mountain Cancer Center Boulder

Boulder, CO

Open and Accepting

Rocky Mountain Cancer Centers - Centennial

Centennial, CO

Open and Accepting

Littleton Adventist Hospital

Centennial, CO

Open and Accepting

Centura Penrose Hospital

Colorado Springs, CO

Open and Accepting

Rocky Mountain Cancer Center - Penrose Hospital Colorado Springs

Colorado Springs, CO

Open and Accepting

St. Francis Medical Center Catholic Health Initiatives

Colorado Springs, CO

Open and Accepting

The Women's Imaging Center

Denver, CO

Open and Accepting

Porter Adventist Hospital

Denver, CO

Temporarily Suspended

Rocky Mountain Cancer Centers (Midtown)

Denver, CO

Open and Accepting

Rocky Mountain Cancer Centers (Rose Medical) Denver

Denver, CO

Open and Accepting

HealthOne Rose Medical Center

Denver, CO

Temporarily Suspended

Western Surgical Care

Denver, CO

Temporarily Suspended

Centura Mercy Hospital

Durango, CO

Open and Accepting

Centura Southwest Oncology

Durango, CO

Open and Accepting

Mountain Blue Cancer Care Center

Englewood, CO

Open and Accepting

Rocky Mountain Cancer Centers - Englewood Swedish Medical Center

Englewood, CO

Open and Accepting

The Melanoma and Skin Cancer Institute

Englewood, CO

Open and Accepting

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Open and Accepting

Cancer Care and Hematology-Fort Collins

Fort Collins, CO

Open and Accepting

UCHealth Greeley Hospital

Greeley, CO

Open and Accepting

Rocky Mountain Cancer Centers - Lakewood

Lakewood, CO

Open and Accepting

Centura St. Anthony Hospital

Lakewood, CO

Open and Accepting

Rocky Mountain Cancer Center Littleton

Littleton, CO

Open and Accepting

HealthOne Sky Ridge Medical Center

Lone Tree, CO

Temporarily Suspended

Centura Longmont United Hospital

Longmont, CO

Open and Accepting

Medical Center of the Rockies

Loveland, CO

Open and Accepting

Centura Parker Adventist Hospital

Parker, CO

Open and Accepting

Saint Mary Corwin Medical Center

Pueblo, CO

Open and Accepting

Rocky Mountain Cancer Center - Thornton

Thornton, CO

Open and Accepting

Connecticut

West Haven VA Medical Center

West Haven, CT

Open and Accepting

Florida

Morton Plant Hospital

Clearwater, FL

Open and Accepting

Broward Oncology Associates, PA

Fort Lauderdale, FL

Open and Accepting

Watson Clinic Cancer & Research Center Lakeland Regional Health Medical Center

Lakeland, FL

Temporarily Suspended

South Florida Baptist Hospital

Plant City, FL

Open and Accepting