Collection of Tissue Samples for Cancer Research

Recruiting now

Conditions studied: Neoplasms, Lymphomas, Multiple Myeloma, Myelodysplastic Syndrome

In brief

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: * To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. * To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites. Design: * This is a multicenter tissue procurement protocol with NCI as the coordinating center. * For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. * For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. * Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. * This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models. * Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Key facts

Study ID: NCT00900198
Run by: National Cancer Institute (NCI)
People needed: 5000
Starts: 2006-07-06
Last updated by the study team: 2026-06-01

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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 limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).
Patients with invasive fungal infections.
Patients with active and/or uncontrolled infections or who are still recovering from an infection:
All antibiotics, antifungals, or antivirals prescribed for the treatment of an 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.
Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.
Antibiotics being administered topically at a location distant from the planned tissue 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 history of 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 malignancy 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 or hematologic malignancy) 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 or bone marrow aspirate 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:
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 from an infection:

Where it is running

Ohio State University — Columbus, Ohio, United States (enrolling)
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
Indiana University - Purdue — Indianapolis, Indiana, United States (enrolling)
University of Iowa — Iowa City, Iowa, United States (enrolling)
Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
Fred Hutchinson — Seattle, Washington, United States (enrolling)
National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Emory University — Atlanta, Georgia, United States (enrolling)
Washington University - St. Louis — St Louis, Missouri, United States (enrolling)
Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
Princess Margaret Hospital Cancer Centre — Toronto, Canada
University of Colorado, Denver — Aurora, Colorado, United States
University of Michigan Ann Arbor — Ann Arbor, Michigan, United States
Medical University of South Carolina — Charleston, South Carolina, United States
University of Utah — Salt Lake City, Utah, United States
University of Virginia, Charlottesville — Charlottesville, Virginia, United States
UC Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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