Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

June 26, 2008 updated by: U.S. Army Medical Research and Development Command

Tissue and Data Acquisition Activity for the Study of Gynecological Disease

The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

Study Overview

Status

Unknown

Conditions

Detailed Description

Cancer arises due to genetic alterations that disrupt numerous cellular functions including proliferation, programmed cell death and senescence, that ultimately control the number of cells in a population. The genetic damage that underlies the development of cancers has a diverse etiology and loss of DNA repair mechanisms also may play a role in allowing mutations to accumulate. Cancers are also characterized by the ability to invade surrounding tissues and to metastasize. Many of the molecular alterations involved in this process have yet to be elucidated.

Gynecologic cancers afflict women of all ages. Cervical cancer is the most common gynecologic malignancy worldwide, accounting for over 400,000 cases annually. Endometrial cancer is the most common gynecologic malignancy with approximately 33,000 new cases being diagnosed annually in American women. Ovarian cancer is the fourth most common cause of cancer related mortality in American women, with approximately 14,000 deaths occurring from it in 2000.

The creation of a tissue repository containing tissue specimens, blood/serum, and molecular extracts (DNA, RNA, protein) will provide a rich source of tissue for future gynecological disease research studies.

Study Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Jonathon Cosin, MD
      • Washington, District of Columbia, United States, 20307
        • Recruiting
        • Gynecologic Disease Center, Walter Reed Army Medical Center
        • Principal Investigator:
          • LTC G. Larry Maxwell, MD
        • Contact:
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Wayne State University Kamanos Cancer Institute
        • Contact:
        • Principal Investigator:
          • Robert T Morris, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Andrew Berchuck, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Jeffrey Fowler, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • Robert Edwards, MD
        • Contact:
      • Windber, Pennsylvania, United States, 15963
        • Not yet recruiting
        • Windber Research Institute
        • Contact:
          • Micheal Liebman, PhD
          • Phone Number: 814-467-9844
        • Principal Investigator:
          • Micheal Liebman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients scheduled to undergo surgery for diagnosis and treatment of a gynecologic disease at one of the participating institutions
  • > = 18 years old
  • Ability to read English

Exclusion Criteria:

  • < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

University of Pittsburgh
Duke University
Walter Reed Army Medical Center
Ohio State University
Medstar Health Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Windber Research Institute

Investigators

  • Principal Investigator: LTC G. Larry Maxwell, MD, Walter Reed Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion

January 1, 2011

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2008

Last Update Submitted That Met QC Criteria

June 26, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-44017
  • W81XWH-05-2-0005
  • A-12818.1a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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