Collection of Tissue Samples for Cancer Research

• INCLUSION CRITERIA - ADULT:

• Patients 18 years of age and older who are being evaluated and/or treated for cancerat the NIH Clinical Center or at participating sites:

• Who have a newly diagnosed malignancy for which they have not yet receivedtreatment, or

• Who have a previously treated malignancy that is now recurrent or currentlyprogressing on treatment indicated by:

• radiographic evidence of tumor growth and/or new metastases, or

• CBC w/differential and/or flow cytometry, or

• documented evidence by the treating physician of signs/symptoms ofclinical disease progression, or

• Who are currently undergoing treatment and for whom disease response has notyet been assessed, ---In this circumstance, specimen collection should occur as distant in timefrom the most recent drug administration as possible such as after completionof a treatment cycle and immediately prior to initiation of the next cycle.

• Patients with ongoing partial response (PR) or stable disease (SD) areeligible.

• For solid tumor diagnoses, confirmation of viable malignancy and/or <90%tumor necrosis, fibrosis, or hemorrhage per the final pathology must bereported to the coordinating site for patients enrolled with ongoing PR orSD at the time of specimen collection.

• For hematologic malignancies, confirmation of viable malignancy must bereported to the coordinating site per the final 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.

At the NIH Clinical Center ONLY:

• At the PIs discretion, specimens may be collected from patients 18 years of age andolder prior to the development of an invasive cancer, who are being evaluated and/ortreated for a confirmed familial cancer syndrome such as but not limited toHereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis ColorectalCancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.

• Specimens, including blood only, can be collected from patients 18 years of age andolder who are being evaluated and/or treated for a hematologic malignancy, includingMyelodysplastic Syndrome (MDS) and/or MDS Myeloproliferative Neoplasm (MDS-MPN),that meet all other adult eligibility criteria.

• Due to the different characteristics of hematologic malignancies versus solidtumor malignancies, including methodology for assessment of disease response,residual disease, and progression, evaluation of these factors fordetermination of protocol eligibility should be made utilizing establishedstandards such as hematopathology, flow cytometry, immunohistochemicalanalysis, etc.

EXCLUSION CRITERIA:

Note: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and/or other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.

• Patients with cancer-like syndromes and/or blood disorders such as but not limitedto systemic mastocytosis, 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 infections or who are still recovering froman infection:

• All antibiotics, antifungals, or antivirals prescribed for the treatment of aninfection 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 1week (7 days) following completion of antibiotics.

• Patients receiving antibiotics, antifungals, or antivirals for prophylaxis arepermissible.

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

• Note: Use of antibiotics for prophylaxis is not an exclusion.

• Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e.,quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known historyof HCV or HBV.

• Patients with Hepatitis A as indicated by anti-HAV IgM reactivity

--Note: Patients that are anti-HAV IgG reactive only are not excluded

• Blood only collections from patients with solid tumors or hematologic malignancydemonstrating partial or stable disease response:

• Blood will not be collected from patients whose disease demonstrates ongoingpartial response or ongoing stable disease given the poor rate of modelgeneration from such specimens.

• Blood will not be collected from patients between doses within a singletreatment cycle.

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

INCLUSION CRITERIA - PEDIATRIC:

• Patients younger than 18 years of age and older than 2 months with a histologicallyor cytologically confirmed diagnosis of cancer (solid tumor or hematologicmalignancy) who are being treated for cancer at the NIH Clinical Center orparticipating clinical sites and who will already be undergoing a clinicallynecessary medical procedure during which tumor tissue will be resected or needlebiopsy tissue or bone marrow aspirate collected. Tissue from neonates will not becollected.

• Ability and willingness to assent to participation, utilizing an explanation that isunderstandable/age appropriate, as well as receiving parental permission.

At the NIH Clinical Center ONLY

-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.

EXCLUSION CRITERIA - PEDIATRIC:

Note: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and/or other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.

• Patients with invasive fungal infections

• Patients with active and/or uncontrolled infections or who are still recovering froman infection:

• Actively febrile patients with uncertain etiology of febrile episode

• All antibiotics should be completed at least 1 week (7 days) prior tocollection

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

• Note: Use of antibiotics for prophylaxis is not an exclusion.

• Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e.,quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known historyof HCV or HBV.

• Patients with Hepatitis A as indicated by anti-HAV IgM reactivity

--Note: Patients that are anti-HAV IgG reactive only are not excluded

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

• Blood only collections from patients with partial or stable disease response:

• Blood will not be collected from patients whose disease demonstrates ongoingpartial response or ongoing stable disease given the poor rate of modelgeneration from such specimens.

• Blood will not be collected from patients between doses within a singletreatment cycle.