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 cancer at the NIH Clinical Center or at participating sites:

  --Who have a newly diagnosed malignancy for which they have not yet received treatment, or

  --Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:

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

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

    --Who are currently undergoing treatment and for whom disease response has not yet been assessed

  • In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.

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

  • Confirmation of viable malignancy and/or <90% tumor necrosis per the final pathology report must be confirmed to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.
• Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.

For participating sites, eligible malignancy for enrollment is limited to solid tumors, lymphoma, and Multiple Myeloma (MM).

-At the NIH Clinical Center ONLY:

--At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and/or treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Nonpolyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer

(HDGC) syndrome.

--Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and/or treated for a hematologic malignancy, including Myelodysplastic 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 solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.

EXCLUSION CRITERIA - ADULT:

• Patients with invasive fungal infections

• 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 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
  • 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 history of HCV or HBV. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

• 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, lymphoma or multiple myeloma demonstrating partial or stable disease response:

  • Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.
  • Blood will not be collected from patients between doses within a single treatment cycle.
• Specimen collections from patients with benign tumors including but not limited to desmoid 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 histologically or cytologically confirmed diagnosis of cancer (solid tumor, lymphoma or multiple myeloma) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue collected. Tissue from neonates will not be collected.
• Ability and willingness to assent to participation, utilizing an explanation that is understandable/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:

• Patients with invasive fungal infections

• 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 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
  • 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 history of HCV or HBV. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

• 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 to desmoid 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 ongoing partial response or ongoing stable disease given the poor rate of model generation from such samples.
  • Blood will not be collected from patients between doses within a single treatment cycle.