Collection of Tissue Samples for Cancer Research
|First Received Date ICMJE||May 9, 2009|
|Last Updated Date||March 6, 2014|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE
||Tissue and fluid collection [ Designated as safety issue: No ]|
|Change History||Complete list of historical versions of study NCT00900198 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Collection of Tissue Samples for Cancer Research|
|Official Title ICMJE||Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)|
-Patients who are being evaluated or are on research protocols at the NIH Clinical Center or at participating sites will be entered onto this screening and tissue procurement protocol for collection of tissue specimens.
-To obtain samples for research purposes from tests performed for clinical indications or research indications on other research protocols, and to obtain samples for research purposes from non-surgical procedures, performed for the sole purpose of obtaining samples for this protocol.
-Patients who are being evaluated for and/or treated on protocols within the NIH Clinical Center or at participating sites.
Once a patient is taken off study, he or she may be re-consented and enrolled at a later time to obtain another research specimen as part of this protocol.
-Patients who are being evaluated and/or treated at the NIH Clinical Center or participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
-Patients who are being evaluated for and/or treated for cancer at the NIH Clinical Center or at participating sites.
sole purpose of obtaining tissue specimens or biological fluids for this protocol.
-Given the risks associated with any invasive procedure, such as tumor biopsy, the
procedure will be discussed in detail with the patients, including the side effects, prior to
obtaining a separate consent for each procedure. A separate consent will not be signed
prior to obtaining samples obtained by minimally invasive measures, such as venipuncture.
-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 identifier and used to perform only those research studies that
are outlined in this protocol.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Tissue Analysis|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients who are being evaluated for and or treated at the NIH Clinical Center or 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.
Age greater than 18 years
|Ages||19 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00900198|
|Other Study ID Numbers ICMJE||060213, 06-C-0213|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP