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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 : February 7, 2023
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 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.

Condition or disease Intervention/treatment
Neoplasms Lymphomas Multiple Myeloma Myelodysplastic Syndrome Procedure: Biopsy

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
Actual Study Start Date : July 6, 2006


Group/Cohort Intervention/treatment
1/Standard
Standard
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.

2/Standard and Preclinical Models
Standard and Preclinical Models
3/Preclinical Models
Preclinical Models
4/Preclinical Models, Pediatric
Preclinical Models, Pediatric



Primary Outcome Measures :
  1. Collection of research samples [ Time Frame: Day of collection ]
    Delinking of patient samples for research



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.


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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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 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.

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
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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
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kathryn S Sutton, MD    404-785-1651    kathryn.sutton@choa.org   
United States, Indiana
Indiana University - Purdue Recruiting
Indianapolis, Indiana, United States, 46202-5262
Contact: Anna Maria Storniolo, MD    317-948-7576    astornio@iu.edu   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Stephanie Chen, MD    319-678-8462    stephanie-chen@uiowa.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nyall London, M.D. PHD    801-547-7851    nyall.london@nih.gov   
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
United States, Missouri
Washington University - St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ryan C. Fields, MD    314-286-1694    rcfields@wustl.edu   
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States
Contact: John Kane, MD    716-845-3284    John.Kane@RoswellPark.org   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jim Rocco, MD, PhD    614-685-6778    James.Rocco@osumc.edu   
Contact: Kyle VanKoevering, MD    (614) 685-6778    kyle.vankoevering@osumc.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Rakesh Sindhi, MD    412-692-7849    Rakesh.Sindhi@chp.edu   
United States, Washington
Fred Hutchinson Recruiting
Seattle, Washington, United States, 28104
Contact: Kelly Smith, MD PhD    206-598-7143    kelsmith@uw.edu   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: James H Doroshow, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00900198    
Other Study ID Numbers: 060213
06-C-0213
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 7, 2023
Last Verified: February 3, 2023

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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
Natural History
Additional relevant MeSH terms:
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Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases