Collection and Storage of Tissue and Blood Samples From Patients With Cancer
Purpose
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.
Condition
- Malignant Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients with a histologically or cytologically confirmed diagnosis of cancer who are being evaluated and/or treated for cancer at participating sites
- 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 invasive fungal infections
- Patients with active and/or uncontrolled infections or who are still recovering from an infection
- Actively febrile patients with uncertain etiology of febrile episode
- All antibiotics 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 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 or HBV without documented resolution; testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated
- Tumor tissue or blood collections from patients with benign tumors including desmoid tumors, carcinoma in situ, or ongoing complete disease response (CR)
- Tumor tissue collected from patients on treatment and demonstrating partial (PR) or stable disease (SD) response will require pathology confirmation sent to the coordinating site of viable malignancy and < 90% tumor necrosis; or
- Documentation of clinical progression by the assessing physician
- Blood collection only:
- Blood will not be collected from patients whose disease demonstrates ongoing partial response or who are currently on treatment with ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such samples
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Ancillary-correlative (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. |
|
Recruiting Locations
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Bronx, New York 10461
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Bronx, New York 10467
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Bronx, New York 10461
More Details
- NCT ID
- NCT02474160
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Study Contact
Detailed Description
PRIMARY OBJECTIVES:
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.