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

National Cancer Institute LAO140 sites in 1 country5,000 target enrollmentMay 19, 2015

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

InterventionsCytology Specimen Collection Procedure

Overview

Phase: Not Applicable
Intervention: Cytology Specimen Collection Procedure
Conditions: Hematopoietic and Lymphatic System Neoplasm
Sponsor: National Cancer Institute LAO
Enrollment: 5000
Locations: 140
Primary Endpoint: Procurement of tissue and blood specimens for research purposes
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 19, 2015

End Date

May 4, 2026

Last Updated

last month

Study Type

Observational

Sex

All

Investigators

Sponsor

National Cancer Institute LAO

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Observational (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.

Intervention: Cytology Specimen Collection Procedure

Outcomes

Primary Outcomes

Procurement of tissue and blood specimens for research purposes

Time Frame: 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).