National Cancer Institute "Cancer Moonshot Biobank"

Prior treatment

• Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
  • For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
• 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

Other illness

• Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
• NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
• 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

Lab values

• 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)

Other

• NCI PDMR EXCLUSION CRITERIA: Patients with complete response

• 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 is being 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 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 optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone 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 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, 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. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 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 at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite 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)