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Collection of Blood, Bone Marrow, Tumor or Tissue Samples

Primary Purpose

Neoplasms, Precancerous Conditions

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Neoplasms focused on measuring Angiogenesis, Drug Resistance, Signal Transduction, EGFR, Survival Factors, Malignancy, Pre-Cancer Condition, Cancer Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Naval Medical Center
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 9, 2002
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00043615
Brief Title
Collection of Blood, Bone Marrow, Tumor or Tissue Samples
Official Title
Acquisition of Blood, Bone Marrow, Tumor, or Tissue Samples
Study Type
Observational

2. Study Status

Record Verification Date
April 10, 2012
Overall Recruitment Status
Completed
Study Start Date
July 29, 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 10, 2012 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Precancerous Conditions
Keywords
Angiogenesis, Drug Resistance, Signal Transduction, EGFR, Survival Factors, Malignancy, Pre-Cancer Condition, Cancer Risk

7. Study Design

Enrollment
74 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin A Camphausen, M.D.
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Naval Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Collection of Blood, Bone Marrow, Tumor or Tissue Samples

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