Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

• Conditions: Endometrial Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Leiomyoma

• Registration Number: NCT00299481
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary

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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-06
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-26
• Last Update Posted: 2008-06-30
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 7000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Gynecologic Disease Center, Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Windber Research Institute; 🇺🇸 Windber, Pennsylvania, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Wayne State University Kamanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States