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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Healthy Volunteers: f
View:

⁃ Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.

⁃ Ability and willingness to assent to participation, utilizing an explanation that is understandable/age appropriate, as well as receiving parental permission.

‣ At the NIH Clinical Center ONLY

• At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.

Locations
United States
California
UC Davis
COMPLETED
Sacramento
Colorado
University of Colorado, Denver
COMPLETED
Aurora
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Indiana
Indiana University - Purdue
RECRUITING
Indianapolis
Maryland
Johns Hopkins University
RECRUITING
Baltimore
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Michigan
University of Michigan Ann Arbor
COMPLETED
Ann Arbor
Missouri
Washington University - St. Louis
RECRUITING
St Louis
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Ohio
Ohio State University
RECRUITING
Columbus
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
COMPLETED
Charleston
Utah
University of Utah
COMPLETED
Salt Lake City
Virginia
University of Virginia, Charlottesville
COMPLETED
Charlottesville
Washington
Fred Hutchinson
RECRUITING
Seattle
Other Locations
Canada
Princess Margaret Hospital Cancer Centre
COMPLETED
Toronto
Contact Information
Primary
Nancy A Moore, R.N.
nancy.moore@nih.gov
(240) 760-6045
Backup
James H Doroshow, M.D.
doroshoj@mail.nih.gov
(240) 781-3320
Time Frame
Start Date: 2006-07-06
Participants
Target number of participants: 5000
Treatments
1/Standard
Standard
2/Standard and Preclinical Models
Standard and Preclinical Models
3/Preclinical Models
Preclinical Models
4/Preclinical Models, Pediatric
Preclinical Models, Pediatric
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov