Collection of Blood, Bone Marrow, Tumor or Tissue Samples

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00043615

Collaborator

(none)

Enrollment

Locations

116.4

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Precancerous Conditions

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

74 participants

Official Title:

Acquisition of Blood, Bone Marrow, Tumor, or Tissue Samples

Study Start Date :

Jul 29, 2002

Study Completion Date :

Apr 10, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Naval Medical Center	Bethesda	Maryland	United States	20889
2	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892