Collection of Blood, Bone Marrow, Tumor or Tissue Samples
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2002 |
| End Date: | April 2012 |
Acquisition of Blood, Bone Marrow, Tumor, or Tissue Samples
This study will collect biological samples-blood, bone marrow, tumor or other tissue
samples-for use in cancer-related research. The specimens will be used for various tests of
drug resistance, blood vessel formation, cancer-causing proteins and immune functions. The
purpose is to identify steps in the cancer development process that may serve as targets for
treatment and to test various therapies for current and future cancer treatment clinical
trials.
Individuals 18 years of age and older with cancer or a pre-cancerous condition, such as
colon polyps or cervical dysplasia, are eligible for this study, as are patients at high
risk for cancer. In addition, patients who do not have cancer but require surgery, biopsy or
other procedure for another medical reason may be included as normal specimen donors.
Participants will have about 40 milliliters (3 tablespoons) of blood drawn upon entering the
study and additional 40-ml samples drawn periodically during the course of treatment. No
more than 120 ml of blood will be drawn over a 12-month period. Some patients may require a
surgical procedure or biopsy (removal of tumor tissue) for medical reasons or as part of
their enrollment in a research treatment study. In such cases, a portion of the specimens
collected during those procedures will be used for the research studies in this protocol.
samples-for use in cancer-related research. The specimens will be used for various tests of
drug resistance, blood vessel formation, cancer-causing proteins and immune functions. The
purpose is to identify steps in the cancer development process that may serve as targets for
treatment and to test various therapies for current and future cancer treatment clinical
trials.
Individuals 18 years of age and older with cancer or a pre-cancerous condition, such as
colon polyps or cervical dysplasia, are eligible for this study, as are patients at high
risk for cancer. In addition, patients who do not have cancer but require surgery, biopsy or
other procedure for another medical reason may be included as normal specimen donors.
Participants will have about 40 milliliters (3 tablespoons) of blood drawn upon entering the
study and additional 40-ml samples drawn periodically during the course of treatment. No
more than 120 ml of blood will be drawn over a 12-month period. Some patients may require a
surgical procedure or biopsy (removal of tumor tissue) for medical reasons or as part of
their enrollment in a research treatment study. In such cases, a portion of the specimens
collected during those procedures will be used for the research studies in this protocol.
Patients will be evaluated at NNMC Clinics. Blood samples may be collected at the initial
visit and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by
removal of pleural or peritoneal fluid, or by excisional biopsy, or other procedure. In
general, biopsy tissue will be obtained as an additional sample at the time of a medically
indicated procedure. In some cases, a biopsy may be performed only to obtain a research
sample providing the tumor is accessible with a minimal risk to the patient. Specific risks
will be described in a separate consent to be obtained at the time of the biopsy. Tumor
samples and blood samples will be processed and/or stored for use in research efforts in the
laboratories of the Medical Oncology Branch, Experimental Transplant and Immunology Branch,
or Genetics Branch, Center for Cancer Research, NCI at Navy and NIH.
visit and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by
removal of pleural or peritoneal fluid, or by excisional biopsy, or other procedure. In
general, biopsy tissue will be obtained as an additional sample at the time of a medically
indicated procedure. In some cases, a biopsy may be performed only to obtain a research
sample providing the tumor is accessible with a minimal risk to the patient. Specific risks
will be described in a separate consent to be obtained at the time of the biopsy. Tumor
samples and blood samples will be processed and/or stored for use in research efforts in the
laboratories of the Medical Oncology Branch, Experimental Transplant and Immunology Branch,
or Genetics Branch, Center for Cancer Research, NCI at Navy and NIH.
- INCLUSION CRITERIA:
Patients must have a performance status of ECOG greater than or equal to 3 for admission
to this protocol.
Subjects must be at least 18 years old.
Patients with any malignancy, high-risk, pre-malignant condition (for example, colonic
polyps, cervical dysplasia, atypical ductal hyperplasia or oral leukoplakia), undergoing
reduction mammoplasty or prophylactic mastectomy are eligible.
Patients requiring a surgical procedure for any medical indication can be included on
study. These patients would be considered normal donors (no diagnosis of cancer).
Patients requiring biopsy or any procedure for any medical indication can be included on
study. These patients will be considered normal donors (no diagnosis of cancer).
Patients not requiring biopsy for a medical indication can be included on the study solely
for the purpose of obtaining research samples, including blood, pleural fluid, or
peritoneal fluid, or biopsy samples, providing the biopsy or aspiration procedure is of
minimal risk, i.e., fine needle aspirate, bone marrow aspirate, or excisional biopsy.
We found this trial at
2
sites
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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