Cancer Moonshot Biobank Research Protocol CANCER MOONSHOT BIOBANK

What's the purpose of this trial?

This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.

This trial is currently open and accepting patients.


What will happen during the trial?

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:

* Is consistent with OR has been diagnosed with one of the following:

* Colorectal cancer: Stage IV
* Non-small cell or small cell lung cancer: stage III/IV
* Prostate cancer: metastatic prostate cancer
* Gastric cancer, not otherwise specified (NOS): stage IV
* Esophageal cancer, NOS: stage IV
* Adenocarcinoma of gastroesophageal junction: stage IV
* High grade serous ovarian cancer: stage III/IV
* Invasive breast carcinoma: stage III/IV
* Melanoma: stage III/IV
* Acute myeloid leukemia
* Multiple myeloma

* For the purposes of this study, re-staging is allowed
* Patient should fit in one of the following four clinical scenarios (a-d)

* Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
* Scheduled to begin treatment with a new regimen of standard of care therapy OR
* Currently progressing on a regimen of standard of care therapy OR
* Currently being treated with a regimen standard of care therapy, without evidence of progression
* Requirements for fresh tissue biospecimen collections at enrollment:

* For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment

* For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
* For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
* For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
* The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling

* Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
* Requirements for archival tissue:

* For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
* For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
* Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:

* Contains the cancer type for which the participant is enrolled, and
* Was collected no more than 5 years prior to initiation of therapy, and
* Contains at least a surface area of 5 mm\^2 and optimum surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
* No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
* Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment

* Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
* Blood collection for clinical scenario d must take place within 4 weeks of enrollment
* Age 13 or older
* Any sex and any gender
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)

Exclusion Criteria:

* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
* Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
* Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion

* Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
* Factor X inhibitors are permitted
* Use of anti-platelet drugs are permitted

* Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
* NCI PDMR EXCLUSION CRITERIA: Patients with CRC that is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
* NCI PDMR EXCLUSION CRITERIA: Patients with complete response
* NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
* NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection

* Actively febrile patients with uncertain etiology of febrile episode
* All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
* NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution

Additional Trial Information

Enrollment: 1,000 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

Thomas Hospital

Fairhope, AL

Open and Accepting

Infirmary Cancer Care

Mobile, AL

Open and Accepting

Arizona

Kingman Regional Medical Center

Kingman, AZ

Open and Accepting

California

PCR Oncology

Arroyo Grande, CA

Open and Accepting

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, CA

Open and Accepting

Delaware

Bayhealth Hospital Kent Campus

Dover, DE

Open and Accepting

Bayhealth Hospital Sussex Campus

Milford, DE

Open and Accepting

Florida

Lynn Cancer Institute Baptist Health Boca Raton Regional Hospital

Boca Raton, FL

Open and Accepting

Tampa General Hospital Cancer Institute

Tampa, FL

Open and Accepting

Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Lewis Cancer and Research Pavilion - Summit Cancer Care Suite 300

Savannah, GA

Open and Accepting

Illinois

Illinois CancerCare (Bloomington)

Bloomington, IL

Open and Accepting

John H. Stroger Jr. Hospital of Cook County

Chicago, IL

Open and Accepting

Carle Foundation Hospital (Vermilion)

Danville, IL

Open and Accepting

Cancer Care Specialists of IL - Cancer Care Center of Decatur

Decatur, IL

Open and Accepting

Memorial Health - Decatur Memorial Hospital Memorial Health

Decatur, IL

Open and Accepting

Illinois CancerCare (Galesburg)

Galesburg, IL

Open and Accepting

Carle Foundation Hospital (Mattoon)

Mattoon, IL

Open and Accepting

Good Samaritan Regional Health Center

Mount Vernon, IL

Open and Accepting

Illinois CancerCare - Pekin

Pekin, IL

Open and Accepting

Illinois CancerCare - Peoria

Peoria, IL

Open and Accepting

Carle Cancer Institute

Urbana, IL

Open and Accepting

Illinois CancerCare - Washington

Washington, IL

Open and Accepting

Iowa

McFarland Clinic PC

Ames, IA

Open and Accepting

Iowa Blood and Cancer Care of PCI

Cedar Rapids, IA

Open and Accepting

Oncology Associates at Hall-Perrine Cancer Center Mercy Cedar Rapids

Cedar Rapids, IA

Open and Accepting

Mission Cancer and Blood - Des Moines

Des Moines, IA

Open and Accepting

Louisiana

Our Lady of the Lake Regional Medical Center

Baton Rouge, LA

Open and Accepting

Children's Hospital New Orleans

New Orleans, LA

Open and Accepting

Maine

Harold Alfond Center for Cancer Care MaineGeneral Medical Center

Augusta, ME

Open and Accepting

Waldo County General Hospital MaineHealth

Belfast, ME

Open and Accepting

SMHC Cancer Care - Biddeford MaineHealth

Biddeford, ME

Open and Accepting

SMHC Cancer Care - Brunswick MaineHealth

Brunswick, ME

Open and Accepting

LincolnHealth - Miles Campus and Hospital

Damariscotta, ME

Open and Accepting

Franklin Memorial Hospital

Farmington, ME

Open and Accepting

Saint Mary's Regional Medical Center

Lewiston, ME

Temporarily Suspended

Stephens Memorial Hospital MaineHealth

Norway, ME

Open and Accepting

Maine Medical Center - Bramhall Campus MaineHealth

Portland, ME

Open and Accepting

Penobscot Bay Medical Center

Rockport, ME

Open and Accepting

SMHC Cancer Care - Sanford MaineHealth

Sanford, ME

Open and Accepting

Maine Children's Cancer Program

Scarborough, ME

Open and Accepting

Maine Medical Partners Women's Health - Scarborough

Scarborough, ME

Open and Accepting

MaineHealth Cancer Care - South Portland

South Portland, ME

Open and Accepting

Maine Medical Partners Urology MaineHealth

South Portland, ME

Open and Accepting

Michigan

St. Joseph Mercy Brighton Health Center

Brighton, MI

Open and Accepting

St. Joseph Mercy Canton Health Center

Canton, MI

Open and Accepting

Chelsea Hospital Michigan Cancer Research Consortium

Chelsea, MI

Open and Accepting

Cancer Research Consortium of West Michigan - Spectrum Health Butterworth

Grand Rapids, MI

Open and Accepting

St. Mary Mercy Hospital St. Joe's Health

Livonia, MI

Open and Accepting

St. Joseph Mercy (Oakland)

Pontiac, MI

Open and Accepting

Missouri

Saint Louis Cancer and Breast Institute

Ballwin, MO

Open and Accepting

Freeman Cornell-Beshore Cancer Institute

Joplin, MO

Open and Accepting

Mercy Hospital Joplin

Joplin, MO

Open and Accepting

Mercy Clinic Cancer and Hematology (Rolla)

Rolla, MO

Open and Accepting

Mercy Hospital Springfield

Springfield, MO

Open and Accepting

CoxHealth South Hospital Cox Medical Center South

Springfield, MO

Open and Accepting

Heartland Regional Medical Center

St. Joseph, MO

Open and Accepting

Saint Louis Cancer and Breast Institute (South City)

St. Louis, MO

Open and Accepting

Mercy Hospital South

St. Louis, MO

Open and Accepting

Missouri Baptist Medical Cancer Center

St. Louis, MO

Open and Accepting

Mercy Hospital St. Louis David C. Pratt Cancer Center

St. Louis, MO

Open and Accepting

Mercy Hospital Washington

Washington, MO

Open and Accepting

Nevada

Carson Tahoe Regional Medical Center

Carson City, NV

Open and Accepting

OptumCare Cancer Care at Seven Hills

Henderson, NV

Open and Accepting

Optum Care Cancer Center - Charleston

Las Vegas, NV

Open and Accepting

Hope Cancer Care of Nevada

Las Vegas, NV

Open and Accepting

Cure 4 the Kids Foundation Roseman University of Health Sciences

Las Vegas, NV

Open and Accepting

Comprehensive Cancer Centers of Nevada - Summerlin

Las Vegas, NV

Open and Accepting

Comprehensive Cancer Centers of Nevada (Southwest)

Las Vegas, NV

Open and Accepting

OptumCare Cancer Care at Fort Apache

Las Vegas, NV

Open and Accepting

Comprehensive Cancer Centers of Nevada (Central Valley)

Las Vegas, NV

Open and Accepting

New Hampshire

Saint Joseph Hospital

Nashua, NH

Open and Accepting

New Jersey

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

Newton Medical Center

Newton, NJ

Open and Accepting

Chilton Medical Center

Pequannock Township, NJ

Open and Accepting

Overlook Hospital

Summit, NJ

Open and Accepting

New York

Albert Einstein College of Medicine Montefiore

Bronx, NY

Open and Accepting

Montefiore Medical Center

Bronx, NY

Open and Accepting

Children's Hospital at Montefiore

Bronx, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

North Carolina

East Carolina University Vidant Cancer Care Eddie and Jo Allison Smith Tower

Greenville, NC

Open and Accepting

Vidant Oncology - Kinston

Kinston, NC

Open and Accepting

FirstHealth Moore Regional Hospital

Pinehurst, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Oklahoma

Mercy Hospital Oklahoma City

Oklahoma City, OK

Open and Accepting

South Carolina

Prisma Health - Richland Hospital

Columbia, SC

Open and Accepting

Prisma Health Baptist Hospital

Columbia, SC

Open and Accepting

Gibbs Cancer Center-Gaffney

Gaffney, SC

Open and Accepting

Prisma Health - Greenville Memorial Hospital

Greenville, SC

Open and Accepting

Gibbs Cancer Center-Pelham

Greer, SC

Open and Accepting

MGC Hematology Oncology-Union

Union, SC

Open and Accepting

Virginia

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Open and Accepting

Washington

Valley Medical Center

Renton, WA

Open and Accepting

North Star Lodge Cancer Center

Yakima, WA

Open and Accepting

Wisconsin

Marshfield Medical Center Cancer Center - Eau Claire

Eau Claire, WI

Open and Accepting

Marshfield Medical Center - Hospital

Marshfield, WI

Open and Accepting

Aurora St. Luke's Medical Center

Milwaukee, WI

Open and Accepting

Marshfield Clinic (Minocqua Center)

Minocqua, WI

Open and Accepting

Marshfield Clinic (Rice Lake Center)

Rice Lake, WI

Open and Accepting

Marshfield Clinic Cancer Care (Saint Michael's Hospital)

Stevens Point, WI

Open and Accepting

Marshfield Medical Center St. Clare's Hospital

Weston, WI

Open and Accepting

Marshfield Clinic - Wisconsin Rapids

Wisconsin Rapids, WI

Open and Accepting
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