RecruitingNCT00900198

Collection of Tissue Samples for Cancer Research

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)


Sponsor

National Cancer Institute (NCI)

Enrollment

5,000 participants

Start Date

Jul 6, 2006

Study Type

OBSERVATIONAL

Conditions

Summary

Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Objectives: * To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. * To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Eligibility: -Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites. Design: * This is a multicenter tissue procurement protocol with NCI as the coordinating center. * For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol. * For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits. * Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture. * This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models. * Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.


Eligibility

Min Age: 2 Months

Plain Language Summary

Simplified for easier understanding

This large tissue and sample bank at the NIH is collecting tumor tissue and blood from cancer patients to support research into new cancer treatments and diagnostics. **You may be eligible if...** - You are 18 or older and are being evaluated or treated for cancer at NIH Clinical Center or a participating site - You have a newly diagnosed cancer with no treatment yet, OR a cancer that has come back or is worsening, OR you are currently on treatment and your response has not yet been assessed - You have a partial response or stable disease (with confirmed living tumor tissue) - Children over 2 months old with a confirmed cancer diagnosis who are already having a medically necessary procedure are also eligible at NIH **You may NOT be eligible if...** - You have a cancer-like blood condition without a true malignancy (such as MGUS or systemic mastocytosis) - You have an active, uncontrolled infection - You have HIV, active hepatitis B, hepatitis C, or Hepatitis A (IgM) - You have a benign tumor or complete disease remission - Your blood tests only show partial or stable response to treatment (for blood-only donations) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy

Tissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol.


Locations(17)

UC Davis

Sacramento, California, United States

University of Colorado, Denver

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

Indiana University - Purdue

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins University

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

University of Michigan Ann Arbor

Ann Arbor, Michigan, United States

Washington University - St. Louis

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia, Charlottesville

Charlottesville, Virginia, United States

Fred Hutchinson

Seattle, Washington, United States

Princess Margaret Hospital Cancer Centre

Toronto, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT00900198


Related Trials