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

• Having more than one primary cancer is allowed, if the patient isbeing treated solely for one of the eligible cancers listed above

• Patient should fit in one of the following four clinical scenarios (a-d)

• Undergoing diagnostic workup for one of the diseases listed for which treatmentwill 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, withoutevidence of progression

• Requirements for fresh tissue biospecimen collections at enrollment:

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

• For clinical scenarios a and b, the fresh tissue collection must be priorto starting therapy

• For clinical scenario a, the biospecimen collection must be part of astandard of care medical procedure

• For clinical scenarios b or c, the biospecimen collection may be part of astandard 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 imageguided or direct vision biopsy and is willing and able to undergo a tumorbiopsy for molecular profiling

• Note: For research-only biopsies, the biopsy must not be associatedwith a significant risk of severe or major complications or death;the procedure cannot be a mediastinal, laparoscopic, open orendoscopic biopsy; nor can the procedure be a brain biopsy; nor canthe 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 besubmitted IF AVAILABLE

• For clinical scenarios c and d above, archival tissue as outlined below isREQUIRED

• 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 optimal surface area of 25mm^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 millionbone marrow mononuclear cells, and

• Contains at least 10% tumor content. 70% tumor content is optimal, and

• No more than 1 line of standard of care systemic therapy was administeredfrom the date of archival material collection to the date of initiation oftherapy

• Requirements for blood collection: ALL scenarios require fresh blood collection atenrollment

• Blood collection for clinical scenarios a, b, and c must take place within 1week of fresh tumor specimen collection

• Blood collection for clinical scenario d must take place within 4 weeks ofenrollment, and while patient is on treatment

• Age 13 or older

• Any sex

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

• Ability to understand and willingness to sign an informed consent document. Consentmay be provided by a Legally Authorized Representative (LAR) in accordance with 45CFR 46.102(i)

• NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR)or microsatellite instability-high (MSI-H) status

• NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger attime of collection irrespective of mismatch repair deficient (dMMR) ormicrosatellite instability-high (MSI-H) status

• NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either

• Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)

• African American with triple negative (ER-PR-HER2-)

• NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA),gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML),multiple myeloma (MML)

Exclusion Criteria:

• Treated with or has already begun treatment with a non-standard of care therapeuticagent (investigational) in an interventional clinical trial

• For the purposes of this study, past enrollment in clinical trials whereby thepatient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed

• Uncontrolled intercurrent illness that in the physician's assessment would poseundue 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 physiciandiscretion

• Low molecular weight (LMW) heparin is permitted for prophylactic or therapeuticuse

• 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 complete response

• NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections

• NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections orwho 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 completedat least 1 week (7 days) prior to collection

• No recurrence of fever or other symptoms related to infection for at least 1week (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 knownhistory of HBV/HCV without documented resolution