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NCT02474160 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02474160
Other study ID # NCI-2015-00863
Secondary ID NCI-2015-00863P9
Status Recruiting
Phase
First received
Last updated
Start date May 19, 2015
Est. completion date May 4, 2026

Study information
Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date May 4, 2026
Est. primary completion date May 4, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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 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 - 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Cytology Specimen Collection Procedure
Procurement of tissue and blood samples

Locations
Country Name City State
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States PCR Oncology Arroyo Grande California
United States MultiCare Auburn Medical Center Auburn Washington
United States Augusta University Medical Center Augusta Georgia
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Bronson Battle Creek Battle Creek Michigan
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Cox Cancer Center Branson Branson Missouri
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Illinois CancerCare-Eureka Eureka Illinois
United States Virginia Mason Federal Way Medical Center Federal Way Washington
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States M D Anderson Cancer Center Houston Texas
United States Cancer Center of Kansas-Independence Independence Kansas
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Virginia Mason Lynnwood Medical Center Lynnwood Washington
United States Illinois CancerCare-Macomb Macomb Illinois
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Cancer Center of Kansas - Newton Newton Kansas
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Corewell Health Reed City Hospital Reed City Michigan
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Mayo Clinic in Rochester Rochester Minnesota
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Virginia Mason Medical Center Seattle Washington
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Munson Medical Center Traverse City Michigan
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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). Up to 5 years
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