Collection of Tissue Samples for Cancer Research
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00900198|
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : February 7, 2023
-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.
- 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.
-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.
- 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.
|Condition or disease||Intervention/treatment|
|Neoplasms Lymphomas Multiple Myeloma Myelodysplastic Syndrome||Procedure: Biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)|
|Actual Study Start Date :||July 6, 2006|
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.
2/Standard and Preclinical Models
Standard and Preclinical Models
4/Preclinical Models, Pediatric
Preclinical Models, Pediatric
- Collection of research samples [ Time Frame: Day of collection ]Delinking of patient samples for research
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900198
|Contact: Nancy Moore, R.N.||(240) email@example.com|
|Contact: James H Doroshow, M.D.||(240) firstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Kathryn S Sutton, MD 404-785-1651 email@example.com|
|United States, Indiana|
|Indiana University - Purdue||Recruiting|
|Indianapolis, Indiana, United States, 46202-5262|
|Contact: Anna Maria Storniolo, MD 317-948-7576 firstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Stephanie Chen, MD 319-678-8462 email@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Nyall London, M.D. PHD 801-547-7851 firstname.lastname@example.org|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 email@example.com|
|United States, Missouri|
|Washington University - St. Louis||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Ryan C. Fields, MD 314-286-1694 firstname.lastname@example.org|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States|
|Contact: John Kane, MD 716-845-3284 John.Kane@RoswellPark.org|
|United States, Ohio|
|Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Jim Rocco, MD, PhD 614-685-6778 James.Rocco@osumc.edu|
|Contact: Kyle VanKoevering, MD (614) 685-6778 email@example.com|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213-2582|
|Contact: Rakesh Sindhi, MD 412-692-7849 Rakesh.Sindhi@chp.edu|
|United States, Washington|
|Seattle, Washington, United States, 28104|
|Contact: Kelly Smith, MD PhD 206-598-7143 firstname.lastname@example.org|
|Principal Investigator:||James H Doroshow, M.D.||National Cancer Institute (NCI)|