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Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

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ClinicalTrials.gov Identifier: NCT00299481
Recruitment Status : Unknown
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : March 6, 2006
Last Update Posted : June 30, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease
Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Leiomyoma

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 Design

Study Type : Observational
Estimated Enrollment : 7000 participants
Time Perspective: Prospective
Official Title: Tissue and Data Acquisition Activity for the Study of Gynecological Disease
Study Start Date : March 2006
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299481


Contacts
Contact: Cynthia A Perry, CIP (202) 782-8461 cynthia.perry@amedd.army.mil
Contact: Karen Livornese, RCN, BSN, CCRC (202) 782-6244 Karen.Livornese@amedd.army.mil

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Velega E Roberts, RN, MS    202-877-8517    Velega.E.Roberts@medstar.net   
Principal Investigator: Jonathon Cosin, MD         
Gynecologic Disease Center, Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Cynthia A Perry, MS    (202) 782-8461    Cynthia.Perry@amedd.army.mil   
Contact: Karen Livornese, RNC, BSN, CCRC    (202) 782-6244    Karen.Livornese@amedd.army.mil   
Principal Investigator: LTC G. Larry Maxwell, MD         
United States, Michigan
Wayne State University Kamanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Alison Fried    313-576-9446    afried@med.wayne.edu   
Principal Investigator: Robert T Morris, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Barbara Walukas, RN    919-684-6159    barbara.walukas@duke.edu   
Principal Investigator: Andrew Berchuck, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Michele Vaughan    614-582-0280    vaughan-2@medctr.osu.edu   
Principal Investigator: Jeffrey Fowler, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Tracy Davis, RN    412-641-1157    tdavis@mail.magee.edu   
Principal Investigator: Robert Edwards, MD         
Windber Research Institute Not yet recruiting
Windber, Pennsylvania, United States, 15963
Contact: Micheal Liebman, PhD    814-467-9844      
Principal Investigator: Micheal Liebman, PhD         
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
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

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:
Neoplasms
Leiomyoma
Myofibroma
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial 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 Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases