National Cancer Institute “Cancer Moonshot Biobank”

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