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
Enrollment
140
Locations
83.6
Anticipated Duration (Months)
35.7
Patients Per Site
0.4
Patients Per Site Per Month

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, 2022
Anticipated Study Completion Date :
May 4, 2022

Arms and Interventions

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1University of Alabama at Birmingham Cancer CenterBirminghamAlabamaUnited States35233
    2Mercy Hospital Fort SmithFort SmithArkansasUnited States72903
    3PCR OncologyArroyo GrandeCaliforniaUnited States93420
    4City of Hope Comprehensive Cancer CenterDuarteCaliforniaUnited States91010
    5USC / Norris Comprehensive Cancer CenterLos AngelesCaliforniaUnited States90033
    6University of Colorado HospitalAuroraColoradoUnited States80045
    7Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticutUnited States06510
    8Yale UniversityNew HavenConnecticutUnited States06520
    9Delaware Clinical and Laboratory Physicians PANewarkDelawareUnited States19713
    10Helen F Graham Cancer CenterNewarkDelawareUnited States19713
    11Medical Oncology Hematology Consultants PANewarkDelawareUnited States19713
    12Christiana Care Health System-Christiana HospitalNewarkDelawareUnited States19718
    13Christiana Care Health System-Wilmington HospitalWilmingtonDelawareUnited States19801
    14Augusta University Medical CenterAugustaGeorgiaUnited States30912
    15Saint Joseph Medical CenterBloomingtonIllinoisUnited States61701
    16Illinois CancerCare-BloomingtonBloomingtonIllinoisUnited States61704
    17Illinois CancerCare-CantonCantonIllinoisUnited States61520
    18Memorial Hospital of CarbondaleCarbondaleIllinoisUnited States62902
    19Illinois CancerCare-CarthageCarthageIllinoisUnited States62321
    20Centralia Oncology ClinicCentraliaIllinoisUnited States62801
    21John H Stroger Jr Hospital of Cook CountyChicagoIllinoisUnited States60612
    22Cancer Care Specialists of Illinois - DecaturDecaturIllinoisUnited States62526
    23Decatur Memorial HospitalDecaturIllinoisUnited States62526
    24Crossroads Cancer CenterEffinghamIllinoisUnited States62401
    25Illinois CancerCare-EurekaEurekaIllinoisUnited States61530
    26Illinois CancerCare-GalesburgGalesburgIllinoisUnited States61401
    27Western Illinois Cancer Treatment CenterGalesburgIllinoisUnited States61401
    28Illinois CancerCare-Kewanee ClinicKewaneeIllinoisUnited States61443
    29Illinois CancerCare-MacombMacombIllinoisUnited States61455
    30Good Samaritan Regional Health CenterMount VernonIllinoisUnited States62864
    31Cancer Care Center of O'FallonO'FallonIllinoisUnited States62269
    32Illinois CancerCare-Ottawa ClinicOttawaIllinoisUnited States61350
    33Radiation Oncology of Northern IllinoisOttawaIllinoisUnited States61350
    34Illinois CancerCare-PekinPekinIllinoisUnited States61554
    35OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterPekinIllinoisUnited States61554
    36Illinois CancerCare-PeoriaPeoriaIllinoisUnited States61615
    37OSF Saint Francis Radiation Oncology at Peoria Cancer CenterPeoriaIllinoisUnited States61615
    38Methodist Medical Center of IllinoisPeoriaIllinoisUnited States61636
    39OSF Saint Francis Medical CenterPeoriaIllinoisUnited States61637
    40Illinois CancerCare-PeruPeruIllinoisUnited States61354
    41Valley Radiation OncologyPeruIllinoisUnited States61354
    42Illinois CancerCare-PrincetonPrincetonIllinoisUnited States61356
    43Central Illinois Hematology Oncology CenterSpringfieldIllinoisUnited States62702
    44Southern Illinois University School of MedicineSpringfieldIllinoisUnited States62702
    45Springfield ClinicSpringfieldIllinoisUnited States62702
    46Memorial Medical CenterSpringfieldIllinoisUnited States62781
    47Cancer Center of Kansas - ChanuteChanuteKansasUnited States66720
    48Cancer Center of Kansas - Dodge CityDodge CityKansasUnited States67801
    49Cancer Center of Kansas - El DoradoEl DoradoKansasUnited States67042
    50Cancer Center of Kansas - Fort ScottFort ScottKansasUnited States66701
    51Cancer Center of Kansas-IndependenceIndependenceKansasUnited States67301
    52Cancer Center of Kansas-KingmanKingmanKansasUnited States67068
    53Lawrence Memorial HospitalLawrenceKansasUnited States66044
    54Cancer Center of Kansas-LiberalLiberalKansasUnited States67905
    55Cancer Center of Kansas-ManhattanManhattanKansasUnited States66502
    56Cancer Center of Kansas - NewtonNewtonKansasUnited States67114
    57Cancer Center of Kansas - ParsonsParsonsKansasUnited States67357
    58Cancer Center of Kansas - PrattPrattKansasUnited States67124
    59Cancer Center of Kansas - SalinaSalinaKansasUnited States67401
    60Cancer Center of Kansas - WellingtonWellingtonKansasUnited States67152
    61Associates In Womens HealthWichitaKansasUnited States67208
    62Cancer Center of Kansas-Wichita Medical Arts TowerWichitaKansasUnited States67208
    63Ascension Via Christi Hospitals WichitaWichitaKansasUnited States67214
    64Cancer Center of Kansas - WichitaWichitaKansasUnited States67214
    65Wesley Medical CenterWichitaKansasUnited States67214
    66Cancer Center of Kansas - WinfieldWinfieldKansasUnited States67156
    67Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandUnited States21287
    68Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215
    69Saint Joseph Mercy HospitalAnn ArborMichiganUnited States48106
    70Bronson Battle CreekBattle CreekMichiganUnited States49017
    71Mercy Health Saint Mary'sGrand RapidsMichiganUnited States49503
    72Spectrum Health at Butterworth CampusGrand RapidsMichiganUnited States49503
    73West Michigan Cancer CenterKalamazooMichiganUnited States49007
    74Borgess Medical CenterKalamazooMichiganUnited States49048
    75Saint Mary Mercy HospitalLivoniaMichiganUnited States48154
    76Mercy Health Mercy CampusMuskegonMichiganUnited States49444
    77Lakeland Hospital NilesNilesMichiganUnited States49120
    78Spectrum Health Reed City HospitalReed CityMichiganUnited States49677
    79Lakeland Medical Center Saint JosephSaint JosephMichiganUnited States49085
    80Marie Yeager Cancer CenterSaint JosephMichiganUnited States49085
    81Munson Medical CenterTraverse CityMichiganUnited States49684
    82Mayo Clinic in RochesterRochesterMinnesotaUnited States55905
    83Baptist Memorial Hospital and Cancer Center-OxfordOxfordMississippiUnited States38655
    84Central Care Cancer Center - BolivarBolivarMissouriUnited States65613
    85Parkland Health Center-Bonne TerreBonne TerreMissouriUnited States63628
    86Cox Cancer Center BransonBransonMissouriUnited States65616
    87Saint Francis Medical CenterCape GirardeauMissouriUnited States63703
    88Southeast Cancer CenterCape GirardeauMissouriUnited States63703
    89Capital Region Southwest CampusJefferson CityMissouriUnited States65109
    90Freeman Health SystemJoplinMissouriUnited States64804
    91Mercy Hospital JoplinJoplinMissouriUnited States64804
    92Delbert Day Cancer Institute at PCRMCRollaMissouriUnited States65401
    93Mercy Clinic-Rolla-Cancer and HematologyRollaMissouriUnited States65401
    94Heartland Regional Medical CenterSaint JosephMissouriUnited States64506
    95Saint Louis Cancer and Breast Institute-South CitySaint LouisMissouriUnited States63109
    96Washington University School of MedicineSaint LouisMissouriUnited States63110
    97Mercy Hospital SouthSaint LouisMissouriUnited States63128
    98Missouri Baptist Medical CenterSaint LouisMissouriUnited States63131
    99Mercy Hospital Saint LouisSaint LouisMissouriUnited States63141
    100Sainte Genevieve County Memorial HospitalSainte GenevieveMissouriUnited States63670
    101Mercy Hospital SpringfieldSpringfieldMissouriUnited States65804
    102CoxHealth South HospitalSpringfieldMissouriUnited States65807
    103Missouri Baptist Sullivan HospitalSullivanMissouriUnited States63080
    104Missouri Baptist Outpatient Center-Sunset HillsSunset HillsMissouriUnited States63127
    105Cancer and Blood Specialists-HendersonHendersonNevadaUnited States89052
    106Cancer and Blood Specialists-ShadowLas VegasNevadaUnited States89106
    107HealthCare Partners Medical Group Oncology/Hematology-Maryland ParkwayLas VegasNevadaUnited States89109
    108HealthCare Partners Medical Group Oncology/Hematology-San MartinLas VegasNevadaUnited States89113
    109Cancer Therapy and Integrative MedicineLas VegasNevadaUnited States89121
    110Cancer and Blood Specialists-TenayaLas VegasNevadaUnited States89128
    111HealthCare Partners Medical Group Oncology/Hematology-TenayaLas VegasNevadaUnited States89128
    112Comprehensive Cancer Centers of NevadaLas VegasNevadaUnited States89148
    113OptumCare Cancer Care at Fort ApacheLas VegasNevadaUnited States89148
    114HealthCare Partners Medical Group Oncology/Hematology-Centennial HillsLas VegasNevadaUnited States89149
    115Comprehensive Cancer Centers of Nevada - Central ValleyLas VegasNevadaUnited States89169
    116Montefiore Medical Center-Einstein CampusBronxNew YorkUnited States10461
    117Montefiore Medical Center-Weiler HospitalBronxNew YorkUnited States10461
    118Montefiore Medical Center - Moses CampusBronxNew YorkUnited States10467
    119NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew YorkUnited States10032
    120UNC Lineberger Comprehensive Cancer CenterChapel HillNorth CarolinaUnited States27599
    121Duke University Medical CenterDurhamNorth CarolinaUnited States27710
    122Mercy Hospital Oklahoma CityOklahoma CityOklahomaUnited States73120
    123Baptist Memorial Hospital and Cancer Center-MemphisMemphisTennesseeUnited States38120
    124M D Anderson Cancer CenterHoustonTexasUnited States77030
    125MultiCare Auburn Medical CenterAuburnWashingtonUnited States98001
    126Virginia Mason Bainbridge Island Medical CenterBainbridge IslandWashingtonUnited States98110
    127Virginia Mason Federal Way Medical CenterFederal WayWashingtonUnited States98002
    128MultiCare Gig Harbor Medical ParkGig HarborWashingtonUnited States98335
    129Virginia Mason Lynnwood Medical CenterLynnwoodWashingtonUnited States98036
    130MultiCare Good Samaritan HospitalPuyallupWashingtonUnited States98372
    131Virginia Mason Medical CenterSeattleWashingtonUnited States98101
    132Marshfield Clinic-Chippewa CenterChippewa FallsWisconsinUnited States54729
    133Marshfield Clinic Cancer Center at Sacred HeartEau ClaireWisconsinUnited States54701
    134Gundersen Lutheran Medical CenterLa CrosseWisconsinUnited States54601
    135Marshfield Medical Center-MarshfieldMarshfieldWisconsinUnited States54449
    136Marshfield Clinic-Minocqua CenterMinocquaWisconsinUnited States54548
    137Marshfield Medical Center-Rice LakeRice LakeWisconsinUnited States54868
    138Ascension Saint Michael's HospitalStevens PointWisconsinUnited States54481
    139Marshfield Clinic-Wausau CenterWausauWisconsinUnited States54401
    140Marshfield Medical Center - WestonWestonWisconsinUnited States54476

    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:
    Jan 5, 2022
    Last Verified:
    Nov 1, 2021

    Study Results

    No Results Posted as of Jan 5, 2022