What this study is
This study 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.
What's being tested
- Cytology Specimen Collection Procedure
Intervention · OTHER
Procurement of tissue and blood samples
Study details
- Official title
- Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)
- Sponsor
- National Cancer Institute LAO
- Conditions
- Hematopoietic and Lymphatic System Neoplasm · Malignant Solid Neoplasm · Metastatic Malignant Solid Neoplasm · Recurrent Malignant Solid Neoplasm
- Enrolling
- 5,000 people
- Starts
- 2015-05-19
- Est. completion
- 2028-05-04
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 2 Months and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients older than 2 months of age 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; Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy
- 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 histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria
- Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment
- Patients with a solid tumor or hematologic 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, OR; CBC w/differential and/or flow cytometry for hematologic malignancies
- 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 residual malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
- Patients with ongoing partial response (PR) or stable disease (SD) are eligible
- Confirmation of viable malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry 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
- For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines
You can't join if
- Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)
- Patients with invasive fungal infections
- Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection
- Actively febrile patients with uncertain etiology of febrile episode
- All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection; Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded
- No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
- Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible
- Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (140)
18 openContact for 11 of 18 open sites
- Jay W. Carlson · Principal investigator
- Recruiting
Augusta University Medical Center
Augusta, Georgia, United States
- Contact706-721-2388ga_cares@augusta.edu
- Anand P. Jillella · Principal investigator
RecruitingJohn H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
- Contact312-864-5204
- Deimante M. Tamkus · Principal investigator
RecruitingSSM Health Good Samaritan
Mount Vernon, Illinois, United States
RecruitingCorewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
- Contact616-391-1230crcwm-regulatory@crcwm.org
- Kathleen Y. Butler · Principal investigator
RecruitingBaptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
- Contact901-226-1366BCCclintrials@bmhcc.org
- Raymond U. Osarogiagbon · Principal investigator
Recruiting- Recruiting
- Recruiting
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
RecruitingHeartland Regional Medical Center
Saint Joseph, Missouri, United States
Recruiting- Recruiting
- Recruiting
- Recruiting
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
- Contact212-342-5162cancerclinicaltrials@cumc.columbia.edu
- Bret Taback · Principal investigator
Recruiting- Recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
- Contact901-226-1366BCCclintrials@bmhcc.org
- Raymond U. Osarogiagbon · Principal investigator
RecruitingMultiCare Tacoma General Hospital
Tacoma, Washington, United States
- Contact253-403-3229research@multicare.org
- John A. Keech · Principal investigator
RecruitingUniversity of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
SuspendedPCR Oncology
Arroyo Grande, California, United States
Active, not recruitingCity of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruitingUSC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Active, not recruitingUCHealth University of Colorado Hospital
Aurora, Colorado, United States
Active, not recruitingSmilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Active, not recruitingYale University
New Haven, Connecticut, United States
Active, not recruitingDelaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Active, not recruitingHelen F Graham Cancer Center
Newark, Delaware, United States
Active, not recruitingMedical Oncology Hematology Consultants PA
Newark, Delaware, United States
Active, not recruitingChristiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Active, not recruitingChristiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Active, not recruitingOSF Saint Joseph Medical Center
Bloomington, Illinois, United States
Active, not recruitingIllinois CancerCare-Bloomington
Bloomington, Illinois, United States
SuspendedIllinois CancerCare-Canton
Canton, Illinois, United States
SuspendedMemorial Hospital of Carbondale
Carbondale, Illinois, United States
SuspendedIllinois CancerCare-Carthage
Carthage, Illinois, United States
SuspendedCentralia Oncology Clinic
Centralia, Illinois, United States
SuspendedCancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Active, not recruitingDecatur Memorial Hospital
Decatur, Illinois, United States
Active, not recruitingCrossroads Cancer Center
Effingham, Illinois, United States
SuspendedIllinois CancerCare-Eureka
Eureka, Illinois, United States
SuspendedIllinois CancerCare-Galesburg
Galesburg, Illinois, United States
SuspendedWestern Illinois Cancer Treatment Center
Galesburg, Illinois, United States
SuspendedIllinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
SuspendedIllinois CancerCare-Macomb
Macomb, Illinois, United States
SuspendedCancer Care Center of O'Fallon
O'Fallon, Illinois, United States
SuspendedIllinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
SuspendedRadiation Oncology of Northern Illinois
Ottawa, Illinois, United States
SuspendedIllinois CancerCare-Pekin
Pekin, Illinois, United States
SuspendedOSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, United States
SuspendedIllinois CancerCare-Peoria
Peoria, Illinois, United States
SuspendedOSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States
SuspendedMethodist Medical Center of Illinois
Peoria, Illinois, United States
SuspendedOSF Saint Francis Medical Center
Peoria, Illinois, United States
SuspendedIllinois CancerCare-Peru
Peru, Illinois, United States
SuspendedValley Radiation Oncology
Peru, Illinois, United States
SuspendedIllinois CancerCare-Princeton
Princeton, Illinois, United States
SuspendedCentral Illinois Hematology Oncology Center
Springfield, Illinois, United States
Active, not recruitingSouthern Illinois University School of Medicine
Springfield, Illinois, United States
SuspendedSpringfield Clinic
Springfield, Illinois, United States
SuspendedSpringfield Memorial Hospital
Springfield, Illinois, United States
SuspendedCancer Center of Kansas - Chanute
Chanute, Kansas, United States
Active, not recruitingCancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Active, not recruitingCancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Active, not recruitingCancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Active, not recruitingCancer Center of Kansas-Independence
Independence, Kansas, United States
Active, not recruitingCancer Center of Kansas-Kingman
Kingman, Kansas, United States
Active, not recruitingLawrence Memorial Hospital
Lawrence, Kansas, United States
Active, not recruitingCancer Center of Kansas-Liberal
Liberal, Kansas, United States
Active, not recruitingCancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Active, not recruitingCancer Center of Kansas - Newton
Newton, Kansas, United States
Active, not recruitingCancer Center of Kansas - Parsons
Parsons, Kansas, United States
Active, not recruitingCancer Center of Kansas - Pratt
Pratt, Kansas, United States
Active, not recruitingCancer Center of Kansas - Salina
Salina, Kansas, United States
Active, not recruitingCancer Center of Kansas - Wellington
Wellington, Kansas, United States
Active, not recruitingAssociates In Womens Health
Wichita, Kansas, United States
Active, not recruitingCancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Active, not recruitingAscension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Active, not recruitingCancer Center of Kansas - Wichita
Wichita, Kansas, United States
Active, not recruitingWesley Medical Center
Wichita, Kansas, United States
Active, not recruitingCancer Center of Kansas - Winfield
Winfield, Kansas, United States
Active, not recruitingJohns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Active, not recruitingDana-Farber Cancer Institute
Boston, Massachusetts, United States
Active, not recruitingTrinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Active, not recruitingBronson Battle Creek
Battle Creek, Michigan, United States
SuspendedTrinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
SuspendedWest Michigan Cancer Center
Kalamazoo, Michigan, United States
SuspendedBeacon Kalamazoo
Kalamazoo, Michigan, United States
SuspendedTrinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Active, not recruitingTrinity Health Muskegon Hospital
Muskegon, Michigan, United States
SuspendedCorewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States
SuspendedCorewell Health Reed City Hospital
Reed City, Michigan, United States
SuspendedCorewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
SuspendedCorewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States
SuspendedMunson Medical Center
Traverse City, Michigan, United States
SuspendedMayo Clinic in Rochester
Rochester, Minnesota, United States
Active, not recruitingCentral Care Cancer Center - Bolivar
Bolivar, Missouri, United States
SuspendedParkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States
SuspendedCox Cancer Center Branson
Branson, Missouri, United States
SuspendedMercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
SuspendedSaint Francis Medical Center
Cape Girardeau, Missouri, United States
SuspendedMU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
SuspendedMercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
SuspendedSainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
SuspendedMercy Infusion Center - Chippewa
St Louis, Missouri, United States
SuspendedWashington University School of Medicine
St Louis, Missouri, United States
Active, not recruitingMissouri Baptist Medical Center
St Louis, Missouri, United States
Active, not recruitingMissouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
SuspendedCancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Active, not recruitingCancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States
Active, not recruitingHealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States
Active, not recruitingHealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States
Active, not recruitingCancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States
Active, not recruitingCancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States
Active, not recruitingHealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States
Active, not recruitingComprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Active, not recruitingHealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States
Active, not recruitingComprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Active, not recruitingOptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Active, not recruitingMontefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Active, not recruitingMontefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Active, not recruitingMontefiore Medical Center - Moses Campus
The Bronx, New York, United States
Active, not recruitingUNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
SuspendedDuke University Medical Center
Durham, North Carolina, United States
Active, not recruitingUT MD Anderson Cancer Center
Houston, Texas, United States
Active, not recruitingMultiCare Auburn Medical Center
Auburn, Washington, United States
Active, not recruitingVirginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, United States
Active, not recruitingVirginia Mason Federal Way Medical Center
Federal Way, Washington, United States
Active, not recruitingMultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States
Active, not recruitingVirginia Mason Lynnwood Medical Center
Lynnwood, Washington, United States
Active, not recruitingMultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Active, not recruitingVirginia Mason Medical Center
Seattle, Washington, United States
Active, not recruitingMarshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Active, not recruitingMarshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Active, not recruitingGundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
SuspendedMarshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Active, not recruitingMarshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
Active, not recruitingMarshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Active, not recruitingAspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Active, not recruitingMarshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Active, not recruitingMarshfield Medical Center - Weston
Weston, Wisconsin, United States
Active, not recruiting
Study team
Sponsor
National Cancer Institute LAO
Study ID NCI-2015-00863
Principal investigator
James H Doroshow
National Cancer Institute (NCI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.