Collection and Storage of Tissue and Blood Samples From Patients With Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT02474160
Collaborator
(none)
5,000
140
95.6
35.7
0.4

Study Details

Study Description

Brief Summary

This research trial collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Detailed Description

PRIMARY OBJECTIVE:
  1. To procure biologic tissues and materials to generate preclinical models of cancer.
OUTLINE:

Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)
Actual Study Start Date :
May 15, 2015
Anticipated Primary Completion Date :
May 4, 2023
Anticipated Study Completion Date :
May 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Ancillary-correlative (tissue and blood procurement)

Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Other: Cytology Specimen Collection Procedure
Procurement of tissue and blood samples
Other Names:
  • Cytologic Sampling
  • Outcome Measures

    Primary Outcome Measures

    1. Procurement of tissue and blood specimens for research purposes [Up to 5 years]

      Tissues and venous blood will be stored, implanted immediately to generate patient-derived xenografts (which require fresh, viable cells), or placed immediately into in vitro cell culture to generate patient-derived cell lines (which require fresh, viable cells).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients 18 year of age or older who are being evaluated, treated or enrolled in a clinical trial for cancer at participating sites

    • Patients with a histologically or cytologically confirmed diagnosis of cancer

    • Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator

    • Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:

    • Radiographic imaging (computed tomography [CT], magnetic resonance imaging [MRI], etc.)

    • Elevated tumor markers

    • Clinical symptoms

    • Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome

    • If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred

    • Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final redacted pathology confirmation must be provided to the coordinating site detailing the confirmed cancer diagnosis for patients enrolled based on the above criteria

    • Patients with a newly diagnosed primary and/or metastatic solid tumor, lymphoma or multiple myeloma malignancy for which they have not yet received treatment

    • Patients with a solid tumor, lymphoma or multiple myeloma malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:

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

    • Documentation by the treating physician of clinical disease progression

    • Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)

    • Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)

    • Specimens should not be collected from patients between doses within a single treatment cycle

    • Confirmation of viable malignancy and/or < 90% tumor necrosis must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology report

    • 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 NCI coordinating site, as indicated in the final post-operative/post-procedure pathology report

    • 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:
    • 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 hepatitis B virus [HBV]-deoxyribonucleic acid [DNA] and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated

    • Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity

    • Patients that are anti-HAV IgG reactive only are eligible

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    3 PCR Oncology Arroyo Grande California United States 93420
    4 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    5 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    6 University of Colorado Hospital Aurora Colorado United States 80045
    7 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    8 Yale University New Haven Connecticut United States 06520
    9 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    10 Helen F Graham Cancer Center Newark Delaware United States 19713
    11 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    12 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    13 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
    14 Augusta University Medical Center Augusta Georgia United States 30912
    15 Saint Joseph Medical Center Bloomington Illinois United States 61701
    16 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    17 Illinois CancerCare-Canton Canton Illinois United States 61520
    18 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    19 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    20 Centralia Oncology Clinic Centralia Illinois United States 62801
    21 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    22 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    23 Decatur Memorial Hospital Decatur Illinois United States 62526
    24 Crossroads Cancer Center Effingham Illinois United States 62401
    25 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    26 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    27 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    28 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    29 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    30 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    31 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    32 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    33 Radiation Oncology of Northern Illinois Ottawa Illinois United States 61350
    34 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    35 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    36 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    37 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    38 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    39 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    40 Illinois CancerCare-Peru Peru Illinois United States 61354
    41 Valley Radiation Oncology Peru Illinois United States 61354
    42 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    43 Central Illinois Hematology Oncology Center Springfield Illinois United States 62702
    44 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    45 Springfield Clinic Springfield Illinois United States 62702
    46 Memorial Medical Center Springfield Illinois United States 62781
    47 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    48 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    49 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    50 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    51 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    52 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    53 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    54 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    55 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    56 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    57 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    58 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    59 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    60 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    61 Associates In Womens Health Wichita Kansas United States 67208
    62 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    63 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    64 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    65 Wesley Medical Center Wichita Kansas United States 67214
    66 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    67 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    68 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    69 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    70 Bronson Battle Creek Battle Creek Michigan United States 49017
    71 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    72 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    73 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    74 Borgess Medical Center Kalamazoo Michigan United States 49048
    75 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    76 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    77 Lakeland Hospital Niles Niles Michigan United States 49120
    78 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    79 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    80 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    81 Munson Medical Center Traverse City Michigan United States 49684
    82 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    83 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi United States 38655
    84 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    85 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
    86 Cox Cancer Center Branson Branson Missouri United States 65616
    87 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    88 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    89 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    90 Freeman Health System Joplin Missouri United States 64804
    91 Mercy Hospital Joplin Joplin Missouri United States 64804
    92 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    93 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    94 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    95 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    96 Washington University School of Medicine Saint Louis Missouri United States 63110
    97 Mercy Hospital South Saint Louis Missouri United States 63128
    98 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    99 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    100 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    101 Mercy Hospital Springfield Springfield Missouri United States 65804
    102 CoxHealth South Hospital Springfield Missouri United States 65807
    103 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    104 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    105 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
    106 Cancer and Blood Specialists-Shadow Las Vegas Nevada United States 89106
    107 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
    108 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
    109 Cancer Therapy and Integrative Medicine Las Vegas Nevada United States 89121
    110 Cancer and Blood Specialists-Tenaya Las Vegas Nevada United States 89128
    111 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
    112 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    113 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    114 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
    115 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    116 Montefiore Medical Center-Einstein Campus Bronx New York United States 10461
    117 Montefiore Medical Center-Weiler Hospital Bronx New York United States 10461
    118 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    119 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    120 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    121 Duke University Medical Center Durham North Carolina United States 27710
    122 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    123 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    124 M D Anderson Cancer Center Houston Texas United States 77030
    125 MultiCare Auburn Medical Center Auburn Washington United States 98001
    126 Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington United States 98110
    127 Virginia Mason Federal Way Medical Center Federal Way Washington United States 98002
    128 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    129 Virginia Mason Lynnwood Medical Center Lynnwood Washington United States 98036
    130 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    131 Virginia Mason Medical Center Seattle Washington United States 98101
    132 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    133 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    134 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    135 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    136 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    137 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    138 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    139 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    140 Marshfield Medical Center - Weston Weston Wisconsin United States 54476

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: James H Doroshow, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT02474160
    Other Study ID Numbers:
    • NCI-2015-00863
    • NCI-2015-00863
    • P9846
    • P9846_R02PAPPHOLD01
    • 9846
    • 9846
    • UM1CA186689
    • UM1CA186691
    • UM1CA186704
    • UM1CA186709
    • UM1CA186717
    • ZIABC011078
    First Posted:
    Jun 17, 2015
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    May 1, 2022

    Study Results

    No Results Posted as of Jun 30, 2022