Clinical Trials /

Collection of Tissue Samples for Cancer Research

NCT00900198

Description:

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) 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 and adult patients from 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 three separate consent forms: one for adult patients at the NIH Clinical Center to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Center only), can opt to donate samples to create preclinical models to study tumor biology and genetics, and to develop new therapies for cancer. - Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
  • Multiple Myeloma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Collection of Tissue Samples for Cancer Research
  • Official Title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Clinical Trial IDs

  • ORG STUDY ID: 060213
  • SECONDARY ID: 06-C-0213
  • NCT ID: NCT00900198

Conditions

  • Neoplasms
  • Lymphomas
  • Multiple Myeloma

Purpose

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) 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 and adult patients from 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 three separate consent forms: one for adult patients at the NIH Clinical Center to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Center only), can opt to donate samples to create preclinical models to study tumor biology and genetics, and to develop new therapies for cancer. - Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

Detailed Description

      Background:

      -Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and
      adult) 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 and
      adult patients from 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 on adult
           patients at the NIH Clinical Center 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 three separate consent forms: one for adult patients at the NIH Clinical
           Center to opt to donate their samples for ongoing research on assay development and
           studies of molecular pathways as listed in Section 8.2; and two for the generation of
           preclinical models (adult and pediatric). Adult patients at the NIH and participating
           sites, and also pediatric patients (NIH Clinical Center only), can opt to donate
           specimens to create preclinical models to study tumor biology and genetics, and to
           develop new therapies for cancer as described in Section 8.1.

        -  Patients may remain on study for the duration of their consent or completion of the
           planned procedure, whichever comes first.
    

Trial Arms

NameTypeDescriptionInterventions
1Subjects being evaluated and/or treated for their malignancy at the NIH Clinical Center (adult and pediatric) and adult subjects at participating sites.

    Eligibility Criteria

            -  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 solid tumor, lymphoma or multiple myeloma malignancy
                      for which they have not yet received treatment, or
    
                   -  Who have a previously treated solid tumor, lymphoma or multiple myeloma
                      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 (adjuvant, neoadjuvant, etc.), are within
                      the first two (2) cycles of 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.
    
                   -  For matched pair collections only (tissue + blood), patients with ongoing partial
                      response (PR) or stable disease (SD) are eligible.
    
                        -  Confirmation of viable malignancy and/or <90% tumor necrosis must be
                           confirmed to the coordinating site, as indicated in the final pathology
                           report, for patients enrolled with PR or SD.
    
              -  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.
    
              -  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.
    
            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 pre-operative 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 (i.e., prolonged) 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.
    
            INCLUSION CRITERIA - PEDIATRIC:
    
              -  Patients younger than 18 years of age 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 and who will already be undergoing a clinically
                 necessary medical procedure during which tumor tissue will be resected or needle
                 biopsy tissue collected.
    
              -  At the PIs discretion, collections may occur from patients with pediatric tumors that
                 14 are generally benign but are known to undergo malignant transformation, e.g.,
                 neurofibromatosis, osteochondromas, pheochromocytoma, etc.
    
              -  Ability to understand and willingness to sign a written informed consent document
                 indicating their willingness to have their tissue or blood/biological fluid samples
                 used for research as outlined in this protocol, or, consent from a parent/guardian
                 with assent from the child.
    
            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 pre-operative 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 (i.e., prolonged) 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.
          
    Maximum Eligible Age:110 Years
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Accrual ceiling met for tissue collection
    Time Frame:At completion date
    Safety Issue:
    Description:Collection of tissue samples

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:National Cancer Institute (NCI)

    Trial Keywords

    • Tissue Collection
    • Biospecimen
    • Assay Development
    • Tissue Acquisition
    • Tissue Biopsies

    Last Updated