RecruitingObservational

Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)

NCT ID: NCT02474160Sponsor: National Cancer Institute LAOLast updated: 2026-03-05

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To procure biologic tissues and materials to generate preclinical models of cancer. OUTLINE: This is an observational study. 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.

Arms & interventions

OtherCytology Specimen Collection Procedure
Procurement of tissue and blood samples

Outcome measures

Primary

Procurement of tissue and blood specimens for research purposes
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).
Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 2 Months and olderHealthy volunteers: No

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Study locations (140)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

Suspended

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

Recruiting

Site Public Contact · Contact

800-378-9373

Jay W. Carlson · Principal Investigator

PCR Oncology

Arroyo Grande, California, 93420

Active Not Recruiting

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Active Not Recruiting

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Active Not Recruiting

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

Active Not Recruiting

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510

Active Not Recruiting

Yale University

New Haven, Connecticut, 06520

Active Not Recruiting

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713

Active Not Recruiting

Helen F Graham Cancer Center

Newark, Delaware, 19713

Active Not Recruiting

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

Active Not Recruiting

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718

Active Not Recruiting

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801

Active Not Recruiting

Augusta University Medical Center

Augusta, Georgia, 30912

Recruiting

Site Public Contact · Contact

706-721-2388 ga_cares@augusta.edu

Sharad A. Ghamande · Principal Investigator

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701

Active Not Recruiting

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

Suspended

Illinois CancerCare-Canton

Canton, Illinois, 61520

Suspended

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

Suspended

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

Suspended

Centralia Oncology Clinic

Centralia, Illinois, 62801

Suspended

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

Recruiting

Site Public Contact · Contact

312-864-5204

Deimante M. Tamkus · Principal Investigator

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

Recruiting

Site Public Contact · Contact

217-876-4762 morganthaler.jodi@mhsil.com

Bryan A. Faller · Principal Investigator

Decatur Memorial Hospital

Decatur, Illinois, 62526

Recruiting

Site Public Contact · Contact

217-876-4762 morganthaler.jodi@mhsil.com

Bryan A. Faller · Principal Investigator

Crossroads Cancer Center

Effingham, Illinois, 62401

Suspended

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

Suspended

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

Suspended

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

Suspended

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

Suspended

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

Suspended

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864

Recruiting

Site Public Contact · Contact

618-899-1894 gayla.hall@ssmhealth.com

Jay W. Carlson · Principal Investigator

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

Suspended

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

Suspended

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 61350

Suspended

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

Suspended

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554

Suspended

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

Suspended

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615

Suspended

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

Suspended

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

Suspended

Illinois CancerCare-Peru

Peru, Illinois, 61354

Suspended

Valley Radiation Oncology

Peru, Illinois, 61354

Suspended

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

Suspended

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702

Active Not Recruiting

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Suspended

Springfield Clinic

Springfield, Illinois, 62702

Suspended

Springfield Memorial Hospital

Springfield, Illinois, 62781

Suspended

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720

Suspended

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801

Suspended

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042

Suspended

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701

Suspended

Cancer Center of Kansas-Independence

Independence, Kansas, 67301

Suspended

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068

Suspended

Lawrence Memorial Hospital

Lawrence, Kansas, 66044

Suspended

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905

Suspended

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, 66502

Suspended

Cancer Center of Kansas - Newton

Newton, Kansas, 67114

Suspended

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357

Suspended

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124

Suspended

Cancer Center of Kansas - Salina

Salina, Kansas, 67401

Suspended

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152

Suspended

Associates In Womens Health

Wichita, Kansas, 67208

Suspended

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208

Suspended

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214

Recruiting

Site Public Contact · Contact

316-291-4774 research@viachristi.org

Dennis F. Moore · Principal Investigator

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214

Recruiting

Site Public Contact · Contact

316-291-4774 research@viachristi.org

Dennis F. Moore · Principal Investigator

Wesley Medical Center

Wichita, Kansas, 67214

Suspended

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156

Suspended

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Active Not Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Active Not Recruiting

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

Active Not Recruiting

Bronson Battle Creek

Battle Creek, Michigan, 49017

Suspended

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

Recruiting

Site Public Contact · Contact

616-391-1230 crcwm-regulatory@crcwm.org

Kathleen Y. Butler · Principal Investigator

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

Suspended

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

Suspended

Ascension Borgess Hospital

Kalamazoo, Michigan, 49048

Suspended

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

Active Not Recruiting

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

Suspended

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

Suspended

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

Suspended

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

Suspended

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085

Suspended

Munson Medical Center

Traverse City, Michigan, 49684

Suspended

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Active Not Recruiting

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655

Recruiting

Site Public Contact · Contact

901-226-1366 BCCclintrials@bmhcc.org

Raymond U. Osarogiagbon · Principal Investigator

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

Suspended

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628

Suspended

Cox Cancer Center Branson

Branson, Missouri, 65616

Suspended

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Suspended

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

Suspended

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

Suspended

Freeman Health System

Joplin, Missouri, 64804

Recruiting

Site Public Contact · Contact

417-347-4030 LJCrockett@freemanhealth.com

Jay W. Carlson · Principal Investigator

Mercy Hospital Joplin

Joplin, Missouri, 64804

Recruiting

Site Public Contact · Contact

417-556-3074 esmeralda.carrillo@mercy.net

Jay W. Carlson · Principal Investigator

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

Recruiting

Site Public Contact · Contact

573-458-7504 research@phelpshealth.org

Jay W. Carlson · Principal Investigator

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

Suspended

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

Recruiting

Site Public Contact · Contact

816-271-7937 Trisha.England2@mymlc.com

Jay W. Carlson · Principal Investigator

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

Suspended

Mercy Hospital Springfield

Springfield, Missouri, 65804

Recruiting

Site Public Contact · Contact

417-269-4520

Jay W. Carlson · Principal Investigator

CoxHealth South Hospital

Springfield, Missouri, 65807

Recruiting

Site Public Contact · Contact

417-269-4520

Jay W. Carlson · Principal Investigator

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, 63109

Suspended

Washington University School of Medicine

St Louis, Missouri, 63110

Active Not Recruiting

Mercy Hospital South

St Louis, Missouri, 63128

Recruiting

Site Public Contact · Contact

314-525-6042 Danielle.Werle@mercy.net

Jay W. Carlson · Principal Investigator

Missouri Baptist Medical Center

St Louis, Missouri, 63131

Recruiting

Site Public Contact · Contact

314-996-5569

Bryan A. Faller · Principal Investigator

Mercy Hospital Saint Louis

St Louis, Missouri, 63141

Recruiting

Site Public Contact · Contact

314-251-7066

Jay W. Carlson · Principal Investigator

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

Suspended

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

Suspended

Cancer and Blood Specialists-Henderson

Henderson, Nevada, 89052

Active Not Recruiting

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, 89106

Active Not Recruiting

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, 89109

Active Not Recruiting

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, 89113

Active Not Recruiting

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, 89121

Active Not Recruiting

Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, 89128

Active Not Recruiting

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, 89128

Active Not Recruiting

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148

Active Not Recruiting

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

Active Not Recruiting

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, 89149

Active Not Recruiting

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169

Active Not Recruiting

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

Recruiting

Site Public Contact · Contact

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Bret Taback · Principal Investigator

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461

Active Not Recruiting

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461

Active Not Recruiting

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467

Active Not Recruiting

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Suspended

Duke University Medical Center

Durham, North Carolina, 27710

Active Not Recruiting

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

Recruiting

Site Public Contact · Contact

405-752-3402

Jay W. Carlson · Principal Investigator

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120

Recruiting

Site Public Contact · Contact

901-226-1366 BCCclintrials@bmhcc.org

Raymond U. Osarogiagbon · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Active Not Recruiting

MultiCare Auburn Medical Center

Auburn, Washington, 98001

Active Not Recruiting

Virginia Mason Bainbridge Island Medical Center

Bainbridge Island, Washington, 98110

Active Not Recruiting

Virginia Mason Federal Way Medical Center

Federal Way, Washington, 98002

Active Not Recruiting

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, 98335

Active Not Recruiting

Virginia Mason Lynnwood Medical Center

Lynnwood, Washington, 98036

Active Not Recruiting

MultiCare Good Samaritan Hospital

Puyallup, Washington, 98372

Active Not Recruiting

Virginia Mason Medical Center

Seattle, Washington, 98101

Active Not Recruiting

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729

Active Not Recruiting

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, 54701

Active Not Recruiting

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

Suspended

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Active Not Recruiting

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

Active Not Recruiting

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

Active Not Recruiting

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

Active Not Recruiting

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401

Active Not Recruiting

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

Active Not Recruiting