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RECRUITING

NCT02474160

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

Sponsor: National Cancer Institute LAO

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Months - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2015-05-19

Completion Date

2028-05-04

Last Updated

2026-10-22

Healthy Volunteers

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm

Interventions

OTHER

Cytology Specimen Collection Procedure

Procurement of tissue and blood samples

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)

Locations (140)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, 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

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Augusta University Medical Center

Augusta, Georgia, United States

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 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

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

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