Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Walter Reed Army Medical Center
Ohio State University
University of Pittsburgh
Duke University
H. Lee Moffitt Cancer Center and Research Institute
Windber Research Institute
Washington Hospital Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00299481
First received: March 2, 2006
Last updated: June 26, 2008
Last verified: June 2008
  Purpose
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.

Condition
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Leiomyoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Tissue and Data Acquisition Activity for the Study of Gynecological Disease

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Estimated Enrollment: 7000
Study Start Date: March 2006
Estimated Study Completion Date: January 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299481

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Gynecologic Disease Center, Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Michigan
Wayne State University Kamanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Windber Research Institute
Windber, Pennsylvania, United States, 15963
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Ohio State University
University of Pittsburgh
Duke University
H. Lee Moffitt Cancer Center and Research Institute
Windber Research Institute
Washington Hospital Center
Investigators
Principal Investigator: LTC G. Larry Maxwell, MD Walter Reed Army Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00299481     History of Changes
Other Study ID Numbers: 04-44017  W81XWH-05-2-0005  A-12818.1a 
Study First Received: March 2, 2006
Last Updated: June 26, 2008
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Tissue Bank
Endometrial neoplasm
uterine cervical neoplasm
ovarian neoplasm
leiomyoma
DNA
RNA
Protein
Serum

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Leiomyoma
Myofibroma
Ovarian Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases
Uterine Cervical Diseases

ClinicalTrials.gov processed this record on December 06, 2016