Collection and Storage of Tissue and Blood Samples From Patients With Cancer

Inclusion Criteria:

• Patients older than 2 months of age who are being evaluated, treated, or enrolled ina clinical trial for cancer at participating sites

• Patients with a histologically or cytologically confirmed diagnosis of cancer

• Patients without histologically or cytologically confirmed diagnosis of cancer, butfor whom approval has been requested and received from the coordinating site studycoordinator

• Requests for coordinating site approval should only be made if the patient'sexisting work-up at the time of the request demonstrates a combination of twoor more of the following indicating the greater likelihood of a cancerousprocess in the assessment of the treating physician:

• Radiographic imaging (computed tomography [CT], magnetic resonance imaging [MRI], etc.)

• Elevated tumor markers

• Clinical symptoms

• Documented risk factors, known genetic changes (mutation, deletion,fusion, etc.), and/or known familial cancer history or syndrome

• Complete blood count (CBC) w/differential indicative of a probablehematologic malignancy

• If the patient will be undergoing surgical resection at a later time and willbe accessible to approach for study participation at that time, resectedmaterial following cancer diagnosis confirmation is preferred

• Important: Additional medical, genetic and/or demographic work-up should not beobtained solely for determination of eligibility for protocol 9846 by thesecriteria. Once available, final histology must be confirmed to the coordinatingsite detailing the cancer diagnosis for patients enrolled based on the abovecriteria

• Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologicmalignancy for which they have not yet received treatment

• Patients with a solid tumor or hematologic malignancy that is recurrent, newlymetastasized, or progressing while on treatment indicated by:

• Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR

• Documentation by the treating physician of clinical disease progression, OR

• CBC w/differential and/or flow cytometry for hematologic malignancies

• Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)

• Specimen collection should occur as distant in time from the most recent drugadministration as possible (e.g., after completion of a treatment cycle andimmediately prior to initiation of the next cycle)

• Specimens should not be collected from patients between doses within a singletreatment cycle

• Confirmation of viable residual malignancy and/or < 90% tumor necrosis,fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the finalpost-operative/post-procedure pathology and/or flow cytometry report

• Patients with ongoing partial response (PR) or stable disease (SD) are eligible

• Confirmation of viable malignancy and/or < 90% tumor necrosis, fibrosis, orhemorrhage must be confirmed to the NCI coordinating site, as indicated in thefinal post-operative/post-procedure pathology and/or flow cytometry report

• Ability to understand and willingness to sign a written informed consent documentindicating their willingness to have their tissue or biologic fluid specimens usedfor research as outlined in this protocol

• For pediatric patients, ability and willingness to assent to participation,using an explanation that is understandable/age appropriate, as well asreceiving parental permission. Signature requirements for pediatric patientscan be adjusted based on local guidelines

Exclusion Criteria:

• Patients with cancer-like syndromes and/or blood disorders such as systemicmastocytosis, Langerhans cell histiocytosis, chronic eosinophilicleukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonalgammopathy of undetermined significance (MGUS)

• Patients with invasive fungal infections

• Patients with active and/or uncontrolled bacterial, fungal, or viral infections orwho are still recovering from an infection

• Actively febrile patients with uncertain etiology of febrile episode

• All antibiotics prescribed for the treatment of a bacterial infection should becompleted at least 1 week (7 days) prior to collection

• Patients with a hematologic malignancy who are treated with an antibiotic,anti-fungal, and/or anti-viral medication for an active infection who thenremain on the treatment for prophylaxis following resolution of theinfection as assessed by the treating physician are not excluded

• No recurrence of fever or other symptoms related to infection for at least 1week (7 days) following completion of antibiotics

• Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxisare permissible

• Antibiotics being administered topically at a location distant from the plannedtissue collection site or eye drops for a localized infection are permissible

• Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e.,quantifiable hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positivehepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HCV, HBV, or HIV; testing for HBV,HCV, HIV or other infections for eligibility will be performed only if clinicallyindicated

• Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgMreactivity

• Patients that are anti-HAV IgG reactive only are eligible

• Specimen collections from patients with benign tumors including but not limited todesmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)