Collection of Blood, Bone Marrow, Tumor or Tissue Samples

NCT00043615 | Completed

• 2 other identifiers: 02025802-C-0258
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms; Precancerous Conditions

Keywords

Angiogenesis; Drug Resistance; Signal Transduction; EGFR; Survival Factors; Malignancy; Pre-Cancer Condition; Cancer Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Naval Medical Center

Bethesda, Maryland, 20889, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neoplasms; Precancerous Conditions

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 9, 2002
• First Posted: August 12, 2002
• Study Start: July 29, 2002
• Study Completion: April 10, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-04-10

Locations

US (2)