Collection of Tissue Samples for Cancer Research
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|ClinicalTrials.gov Identifier: NCT00900198|
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : February 8, 2023
|First Submitted Date||May 9, 2009|
|First Posted Date||May 12, 2009|
|Last Update Posted Date||February 8, 2023|
|Actual Study Start Date||July 6, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Collection of research samples [ Time Frame: Day of collection ]
Delinking of patient samples for research
|Original Primary Outcome Measures
||Tissue and fluid collection|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Collection of Tissue Samples for Cancer Research|
|Official Title||Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)|
-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.
-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.
Patients who are being evaluated and/or treated at the NIH Clinical Center and 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 and at 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 protocol(s) 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 on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include 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 samples 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 samples to create preclinical models.
Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
|Study Design||Observational Model: Case-Only
Time Perspective: Other
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens|
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.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
For participating sites, eligible malignancy for enrollment is limited to solid tumors, lymphoma, and Multiple Myeloma (MM).
-At the NIH Clinical Center ONLY:
--At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and/or treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Nonpolyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer
--Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and/or treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and/or MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.
---Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.
EXCLUSION CRITERIA - ADULT:
INCLUSION CRITERIA - PEDIATRIC:
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.
EXCLUSION CRITERIA - PEDIATRIC:
|Ages||2 Months and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries||Canada|
|Other Study ID Numbers||060213
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Current Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Original Responsible Party||Not Provided|
|Current Study Sponsor||National Cancer Institute (NCI)|
|Original Study Sponsor||Same as current|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 3, 2023|