Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

Ovarian Neoplasms Clinical Trial

Official title:

Tissue and Data Acquisition Activity for the Study of Gynecological Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00299481
• Other study ID #: 04-44017
• Secondary ID: W81XWH-05-2-0005
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2006
• Last updated: June 26, 2008
• Start date: March 2006
• Est. completion date: January 2011

Study information

• Verified date: June 2008
• Source: Walter Reed Army Medical Center
• Contact: Cynthia A Perry, CIP
• Phone: (202) 782-8461
• Email: cynthia.perry[@]amedd.army.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Leiomyoma
• Neoplasms
• Ovarian Neoplasms
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Wayne State University Kamanos Cancer Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Gynecologic Disease Center, Walter Reed Army Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Windber Research Institute	Windber	Pennsylvania

Sponsors (8)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	Duke University, H. Lee Moffitt Cancer Center and Research Institute, Ohio State University, University of Pittsburgh, Walter Reed Army Medical Center, Washington Hospital Center, Windber Research Institute

Country where clinical trial is conducted

United States,