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Collection of Tissue Samples for Cancer Research

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ClinicalTrials.gov Identifier: NCT00900198
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Neoplasms Lymphomas Procedure: Biopsy Phase 1

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; 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
Study Start Date : September 18, 2006
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • Procedure: Biopsy
    Tissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol.


Primary Outcome Measures :
  1. Accrual ceiling met for tissue collection [ Time Frame: At completion date ]
    Collection of tissue samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

    --Documentation of clinical progression by the assessing physician would be acceptable if imaging demonstrating progressive disease has not been obtained.

  • 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.
  • 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.

    --Documentation of clinical progression by the assessing physician would be acceptable if imaging demonstrating progressive disease has not been obtained.

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900198


Contacts
Contact: Nancy Moore, R.N. (240) 760-6045 nancy.moore@nih.gov
Contact: James H Doroshow, M.D. (240) 781-3320 doroshoj@mail.nih.gov

Locations
United States, Indiana
Indiana University Purdue Recruiting
Indianapolis, Indiana, United States, 46202-5262
Contact: Patrick Loehrer, MD    317-944-0920    ploehrer@iupui.edu   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mike Knudson, MD    319-467-5129    c-knudson@uiowa.edu   
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
United States, Missouri
Washington University, St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ryan Fields, MD    314-286-1694    fieldsr@wudosis.wstl.edu   
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14203
Contact: John Kane, MD    716-845-3284    John.Kane@RoswellPark.org   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Jim Rocco, MD    614-685-6778    James.Rocco@osumc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Steven Carroll, MD    843-792-1512    carrolst@musc.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jennifer Pietenpol, PhD    615-936-1512    jennifer.pietenpol@vanderbilt.edu   
United States, Virginia
Univ. of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Chirstopher Moskaluk, MD    434-982-4408    cam5p@virginia.edu   
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 28104
Contact: John Slattery, PhD    206-543-6116    jts@uw.edu   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: James H Doroshow, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00900198     History of Changes
Other Study ID Numbers: 060213
06-C-0213
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 8, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tissue Collection
Biospecimen
Assay Development
Tissue Acquisition
Tissue Biopsies